CompletedNCT03470675Updated Apr 24, 2026Results posted

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

A Phase 4 interventional study of Epidural saline + IV saline and Epidural morphine 3 mg + IV saline in Pain and Postpartum Depression, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Northwestern University · Phase 4, Interventional, and Prevention

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Phase: Phase 4
Study type: Interventional
Enrollment: 67
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Where this study stands

Counted across the records on this site · 2026-11-15

Among 60 studies in Pain by Northwestern University — 1 open to participants now, 4 under way, none of them phase 3. Pain · Northwestern University.

Enrollment: 22nd of 57; 67 · median 50
Started: 2018; with 2 others
Phase 4: 12 of 60; none open now
Registered: 51st of 60; by date

Among the 60 studies in Pain by Northwestern University, this one is the 22nd largest by enrollment of the 57 interventional ones that give a count, is one of 3 that started in 2018, is one of 12 in phase 4, and was the 51st registered.

Pain

10,066 studies on the registry are indexed under Pain; 1,651 are open to participants now.

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Open to participants now

1 of the 60 studies in Pain by Northwestern University is open now, in 1 country. Recruiting first, the newest first:

RecruitingNCT06336447
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Northwestern University · Sites in United States
Ages 18+

By country, each count listing its studies:

United States1

Where they have run

United States55

Who these studies take

Of the 928 Pain studies recruiting now, 383 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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Northwestern University in Pain

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Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

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Coming up

2 of the studies in Pain by Northwestern University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:

Study	Primary completion
NCT06336447Northwestern UniversityVR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain	2026-12-31
NCT05038553Northwestern UniversityChronic Pain in Rheumatoid Arthritis	2027-02-28

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What changed since 2026-09-25

Among the 60 studies in Pain by Northwestern University, from their registry updates:

Nothing recorded among them since 2026-09-25.

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Study summary

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.

This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.

The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.

Conditions studied

Pain
Postpartum Depression

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age >18 years of age
English-speaking
Vaginal delivery (spontaneous or assisted)
A full-term fetus (>37 weeks' gestation)
OASIS as assessed by obstetrical provider
Functional epidural analgesia at time of delivery
Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

Exclusion criteria

Exclusion Criteria:

Previous pelvic surgery
History of chronic pelvic pain
History of recurrent urinary tract infections
Women with known malformations of their urinary tract
True allergies to ketamine and/or morphine
Preeclampsia or hypertensive disorder at the time of delivery
Obstructive sleep apnea

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 67 participants (actual)

Study arms

Placebo comparator
Epidural saline + IV saline
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Drug: Epidural saline + IV saline
Active comparator
Epidural morphine 3 mg + IV saline
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Drug: Epidural morphine 3 mg + IV saline
Active comparator
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Interventions

DrugEpidural saline + IV saline
Sterile saline injection in the epidural catheter and in the intravenous catheter
DrugEpidural morphine 3 mg + IV saline
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
DrugEpidural morphine 3 mg + IV ketamine 0.3 mg/kg
Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter

What researchers measure

Primary outcomes

Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).
Time frame: 1 week after vaginal delivery

Secondary outcomes

Perineal Pain
Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Time frame: Day 1 after delivery
Perineal Pain
Perineal pain day 7 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Time frame: 1 week after delivery
Assessment of Maternal-infant Bonding
Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment (poor) to 95 high maternal infant attachment (good).
Time frame: 1 week after delivery
Presence of Postpartum Depression
Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low- 30 high. High scores indicate potential for depression.
Time frame: 1 week after delivery
Brief Pain Inventory (BPI-ST Short Form) Current Pain
Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.
Time frame: 1 week after delivery
Presence of Postpartum Depression
Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
Time frame: 6 weeks after delivery
Perineal Pain
Perineal pain 6 weeks after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Time frame: 6 weeks after delivery
Assessment of Maternal-infant Bonding
Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
Time frame: 6 weeks after delivery
Brief Pain Inventory (BPI-ST Short Form) Current Pain
Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.
Time frame: 6 weeks after delivery
Perineal Pain
Perineal pain 3 months after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Time frame: 3 months after delivery
Assessment of Maternal-infant Bonding
Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
Time frame: 3 months after delivery
Female Sexual Function
Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function to 36 high sexual function.
Time frame: 3 months after delivery
Brief Pain Inventory (BPI-ST Short Form) Current Pain
Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.
Time frame: 3 months after delivery
Promis 29 Profile (Physical Function Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher physical function.
Time frame: 3 month
Promis 29 Profile (Anxiety Function Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 anxiety rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher anxiety.
Time frame: 3 month
Promis 29 Profile (Depressive Symptoms Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher depression.
Time frame: 3 month
Promis 29 Profile (Fatigue Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of fatigue.
Time frame: 3 month
Promis 29 Profile (Sleep Disturbance Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of sleep disturbance.
Time frame: 3 month
Promis 29 Profile (Social Function Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of social function.
Time frame: 3 month
Promis 29 Profile (Pain Interference Question Only)
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates a higher level of pain interference.
Time frame: 3 month
Perineal Pain
Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good) and 10 highest pain (poor).
Time frame: 1 year after delivery

Results

Posted Apr 24, 2026

Limitations and caveats

This project enrollment was closed early because of loss of funding.

Participant flow

Participant flow — Overall Study
Milestone	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Started	15	26	26
Completed	8	17	21
Not completed	7	9	5
Withdrew: Lost to follow-up	7	9	5

Outcome measures

PrimaryPerineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.

Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).

Time frame:: 1 week after vaginal delivery
Reported as:: Mean · score on a scale

Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.	3.5 (2.3 to 4.7)	2.7 (2.0 to 3.4)	2.4 (1.7 to 3.1)

SecondaryPerineal Pain

Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

Time frame:: Day 1 after delivery
Reported as:: Mean · score on a scale

Perineal Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Perineal Pain	14.4 (10.0 to 18.9)	10.4 (7.9 to 12.9)	12.9 (10.0 to 15.8)

SecondaryPerineal Pain

Perineal pain day 7 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

Time frame:: 1 week after delivery
Reported as:: Mean · score on a scale

Perineal Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Perineal Pain	9.5 (6.9 to 12.1)	9.4 (6.2 to 12.7)	8.9 (6.6 to 11.2)

SecondaryAssessment of Maternal-infant Bonding

Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment (poor) to 95 high maternal infant attachment (good).

Time frame:: 1 week after delivery
Reported as:: Mean · Score on a scale

Assessment of Maternal-infant Bonding
Score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Assessment of Maternal-infant Bonding	82.5 (78.4 to 86.7)	79.1 (73.9 to 84.2)	83.8 (81.8 to 85.9)

SecondaryPresence of Postpartum Depression

Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low- 30 high. High scores indicate potential for depression.

Time frame:: 1 week after delivery
Reported as:: Mean · score on a scale

Presence of Postpartum Depression
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Presence of Postpartum Depression	5.7 (2.9 to 8.6)	7.0 (4.7 to 9.4)	6.7 (4.9 to 9.4)

SecondaryBrief Pain Inventory (BPI-ST Short Form) Current Pain

Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

Time frame:: 1 week after delivery
Reported as:: Mean · score on a scale

Brief Pain Inventory (BPI-ST Short Form) Current Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Brief Pain Inventory (BPI-ST Short Form) Current Pain	3.0 (2.2 to 3.8)	2.3 (1.6 to 3.1)	2.2 (1.6 to 2.9)

SecondaryPresence of Postpartum Depression

Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.

Time frame:: 6 weeks after delivery
Reported as:: Mean · score on a scale

Presence of Postpartum Depression
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Presence of Postpartum Depression	5.1 (2.6 to 7.6)	4.7 (2.8 to 6.6)	4.8 (3.3 to 6.3)

SecondaryPerineal Pain

Perineal pain 6 weeks after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

Time frame:: 6 weeks after delivery
Reported as:: Mean · score on a scale

Perineal Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Perineal Pain	1.7 (.3 to 3.1)	5.2 (1.4 to 9)	3.8 (1.9 to 5.7)

SecondaryAssessment of Maternal-infant Bonding

Time frame:: 6 weeks after delivery
Reported as:: Mean · Score on a scale

Assessment of Maternal-infant Bonding
Score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Assessment of Maternal-infant Bonding	83.2 (78.8 to 87.6)	80.9 (76.8 to 85.1)	85.0 (82.4 to 87.7)

SecondaryBrief Pain Inventory (BPI-ST Short Form) Current Pain

Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

Time frame:: 6 weeks after delivery
Reported as:: Mean · score on a scale

Brief Pain Inventory (BPI-ST Short Form) Current Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Brief Pain Inventory (BPI-ST Short Form) Current Pain	.3 (0 to .6)	.5 (.1 to 1.0)	.7 (.1 to 1.3)

SecondaryPerineal Pain

Perineal pain 3 months after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

Time frame:: 3 months after delivery
Reported as:: Mean · score on a scale

Perineal Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Perineal Pain	.8 (.3 to 2.0)	3.2 (.8 to 5.6)	1 (.4 to 1.7)

SecondaryAssessment of Maternal-infant Bonding

Time frame:: 3 months after delivery
Reported as:: Mean · Scores on a scale

Assessment of Maternal-infant Bonding
Scores on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Assessment of Maternal-infant Bonding	4.0 (2.3 to 5.8)	3.6 (2.0 to 5.3)	4.4 (3.1 to 5.7)

SecondaryFemale Sexual Function

Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function to 36 high sexual function.

Time frame:: 3 months after delivery
Reported as:: Mean · Score on scale 2 low 36 high

Female Sexual Function
Score on scale 2 low 36 high	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Female Sexual Function	13 (8.4 to 17.6)	14.2 (10.2 to 18.2)	14.8 (11.1 to 18.5)

SecondaryBrief Pain Inventory (BPI-ST Short Form) Current Pain

Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

Time frame:: 3 months after delivery
Reported as:: Mean · score on a scale

Brief Pain Inventory (BPI-ST Short Form) Current Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Brief Pain Inventory (BPI-ST Short Form) Current Pain	.2 (.2 to .7)	.6 (0.0 to 1.1)	0.0 (0.0 to 0.2)

SecondaryPromis 29 Profile (Physical Function Question Only)

29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher physical function.

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Physical Function Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Physical Function Question Only)	52.9 (48.4 to 57.5)	54.8 (52.7 to 56.8)	54.8 (52.9 to 56.6)

SecondaryPromis 29 Profile (Anxiety Function Question Only)

29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 anxiety rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher anxiety.

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Anxiety Function Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Anxiety Function Question Only)	44.8 (39.3 to 50.3)	45.3 (43.0 to 53.6)	46.7 (43.9 to 49.6)

SecondaryPromis 29 Profile (Depressive Symptoms Question Only)

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Depressive Symptoms Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Depressive Symptoms Question Only)	45 (42.1 to 48.0)	43 (40.9 to 45.2)	43.6 (41.2 to 45.9)

SecondaryPromis 29 Profile (Fatigue Question Only)

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Fatigue Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Fatigue Question Only)	45.9 (41.6 to 50.3)	48.1 (44.1 to 52.1)	50.0 (47.9 to 53.2)

SecondaryPromis 29 Profile (Sleep Disturbance Question Only)

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Sleep Disturbance Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Sleep Disturbance Question Only)	58.3 (55.6 to 61.0)	56.0 (54.0 to 57.9)	54.8 (51.1 to 58.6)

SecondaryPromis 29 Profile (Social Function Question Only)

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Social Function Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Social Function Question Only)	55.8 (50.7 to 61.0)	53.8 (50.3 to 57.3)	55.3 (52.4 to 58.2)

SecondaryPromis 29 Profile (Pain Interference Question Only)

Time frame:: 3 month
Reported as:: Mean · T score

Promis 29 Profile (Pain Interference Question Only)
T score	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Promis 29 Profile (Pain Interference Question Only)	44 (40.6 to 47.5)	43 (41.4 to 44.4)	43.5 (41.7 to 45.2)

SecondaryPerineal Pain

Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good) and 10 highest pain (poor).

Time frame:: 1 year after delivery
Reported as:: Mean · score on a scale

Perineal Pain
score on a scale	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Perineal Pain	.1 (.1 to .2)	.5 (.1 to 1.1)	.3 (.1 to .5)

Adverse events

Collected over 48 Hours after delivery of baby.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Epidural Saline + IV Saline	0/14 (0%)	0/14 (0%)	4/14 (28.6%)
Epidural Morphine 3 mg + IV Saline	0/26 (0%)	0/26 (0%)	14/26 (53.8%)
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	0/25 (0%)	0/25 (0%)	13/25 (52%)

Most frequent other events

Most frequent other events
Event	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Back AcheMusculoskeletal and connective tissue disorders	1/14	6/26	4/25
HypotensionCardiac disorders	2/14	3/26	2/25
NauseaGastrointestinal disorders	0/14	2/26	3/25
PruritusGeneral disorders	0/14	3/26	2/25
VomitingGastrointestinal disorders	0/14	1/26	2/25
FeverGeneral disorders	0/14	2/26	1/25
Wound ProblemsGeneral disorders	1/14	0/26	0/25
HivesGeneral disorders	0/14	1/26	0/25

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
Mean	34.7 (31.3 to 38.1)	31.2 (27.3 to 35.1)	33.9 (30.5 to 37.4)	33 (27.3 to 38.1)

Sex: Female, Male
Sex: Female, Male(Participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
Female	14	26	25	65
Male	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	6	5	5	16
White	8	18	18	44
More than one race	0	0	0	0
Unknown or Not Reported	0	3	2	5

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
Hispanic LatinX	0	1	1	2
Not LatinX	14	25	24	63

Region of Enrollment
Region of Enrollment(participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
United States	14	26	25	65

Current Smoker
Current Smoker(Participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
Count of participants	1	0	0	1

Gravida
Gravida(number of participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
1 Time	10	17	14	41
2 Times	1	6	9	15
Greater than 2 times	3	3	2	8

Para
Para(number of participants)	Epidural Saline + IV Saline	Epidural Morphine 3 mg + IV Saline	Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg	Total
No births	2	5	3	10
1 birth	11	17	16	44
2 births	1	4	6	11

17 further baseline measures are reported on the registry.

Study locations

1 site

Northwestern University
Chicago, Illinois 60611, United States

References and documents

Publications

Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0. PubMed 26637088 ↗
Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064. PubMed 15507941 ↗
Chang SR, Chen KH, Lee CN, Shyu MK, Lin MI, Lin WA. Relationships between perineal pain and postpartum depressive symptoms: A prospective cohort study. Int J Nurs Stud. 2016 Jul;59:68-78. doi: 10.1016/j.ijnurstu.2016.02.012. Epub 2016 Feb 26. PubMed 27222452 ↗
Bauchat JR, Higgins N, Wojciechowski KG, McCarthy RJ, Toledo P, Wong CA. Low-dose ketamine with multimodal postcesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2011 Jan;20(1):3-9. doi: 10.1016/j.ijoa.2010.10.002. PubMed 21224020 ↗

Study documents

Protocol and statistical analysis plan ↗ · Apr 23, 2019
Informed consent form ↗ · Aug 30, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in May 2024, 70 months.

Results were first posted in Apr 2026, 1 year 11 months after primary completion.

Of 280 non-industry phase 4 interventional studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 70 months is above that.

Counting every sponsor, half of 295 studies reached it within 18 months; a quarter within 8 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 2, 2018
First posted: Mar 20, 2018
StartActual: Jun 27, 2018
Primary completionActual: May 20, 2024
CompletionActual: Jun 20, 2024
Results first posted: Apr 24, 2026
Last update: Apr 24, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03470675
Lead sponsor: Northwestern University
Responsible party: Feyce M. Peralta, MD, MS (Principal Investigator, Northwestern University) — Principal investigator
First posted: Mar 20, 2018
Start date: Jun 27, 2018
Primary completion: May 20, 2024
Completion: Jun 20, 2024
Results posted: Apr 24, 2026
Last update: Apr 24, 2026

Study contacts

Feyce Peralta, MD

principal investigator · Northwestern University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

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