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CompletedNCT03427463Updated Dec 19, 2024Results posted

Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.

An Early Phase 1 interventional study of receiving 0.1 mg IT morphine and recieving 0.05 mg IT morphine in Cesarean Section, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Medical University of South Carolina · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
229
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.

02

Conditions studied

  • Cesarean Section
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • any parturient 18 years of age or older
  • undergoing elective cesarean delivery under spinal anesthesia
  • able to consent to the study and participate in the follow-up.

Exclusion criteria

Exclusion Criteria:

  • any known allergy to morphine
  • general anesthesia
  • urgent or emergent cases
  • any bleeding diathesis or other coagulopathy
  • known G6PD deficiency
  • any known liver disease
  • known alcohol abuse or dependence
  • HELLP syndrome
  • thrombocytopenia or known platelet dysfunction
  • history or active gastrointestinal bleeding
  • acute kidney injury or chronic renal insufficiency
  • contraindication/refusal to spinal anesthestic
  • chronic pain
  • chronic narcotic use
  • illicit drug use
  • allergy to any study related medications
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
229 participants (actual)

Study arms

  • Active comparator
    receiving 0.1 mg IT morphine

    Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

    Drug: receiving 0.1 mg IT morphine

  • Experimental
    recieving 0.05 mg IT morphine

    Patients will receive 0.05 mg of intrathecal morphine

    Drug: recieving 0.05 mg IT morphine

Interventions

  • Drugreceiving 0.1 mg IT morphine

    Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

  • Drugrecieving 0.05 mg IT morphine

    Patients will receive 0.05 mg of intrathecal morphine

05

What researchers measure

Primary outcomes

  1. Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.

    This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.

    Time frame: 24 hours

Secondary outcomes

  1. Time to First Ambulation After C-section

    This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.

    Time frame: up to 48 hours

  2. Opioid Medication Given During the Participant's Hospital Stay.

    This outcome looks at whether or not any opioid medications were given during the participant's hospital stay, reporting the number of subjects who received opioid pain medication during the admission.

    Time frame: From the time of the procedure through discharge, up to 48 hours.

  3. Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.

    Subjective pain with ambulation reported by participants using visual analogue scales (VAS) ranging from 0-100 at the 24-hour post-op time point and 48-hour post-op time point. The lower the number, the better the outcome.

    Time frame: 24-hours post operatively and 48-hours post operatively

  4. Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)

    The presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.

    Time frame: 24 hours post operavtively

  5. Overall Patient Satisfaction With Pain Control

    Patients were asked to mark their satisfaction with pain control using a Visual Analog Scale (VAS) from 0-100. The higher the number, the more satisfied they were with the post-op pain control

    Time frame: 48 hours post-op

06

Results

Posted Dec 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
Started115114
Completed101100
Not completed1414

Outcome measures

PrimaryTime to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.

This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.

Time frame:
24 hours
Reported as:
Median · hours
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
hoursReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.NA (NA to NA)23.5 (14.5 to 38)
SecondaryTime to First Ambulation After C-section

This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.

Time frame:
up to 48 hours
Reported as:
Median · hours
Time to First Ambulation After C-section
hoursReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
Time to First Ambulation After C-section13.6 (0.4 to 72.5)13.7 (2.42 to 75.0)
SecondaryOpioid Medication Given During the Participant's Hospital Stay.

This outcome looks at whether or not any opioid medications were given during the participant's hospital stay, reporting the number of subjects who received opioid pain medication during the admission.

Time frame:
From the time of the procedure through discharge, up to 48 hours.
Reported as:
Count of participants · Participants
Opioid Medication Given During the Participant's Hospital Stay.
ParticipantsReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
Opioid Medication Given During the Participant's Hospital Stay.7474
SecondarySubjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.

Subjective pain with ambulation reported by participants using visual analogue scales (VAS) ranging from 0-100 at the 24-hour post-op time point and 48-hour post-op time point. The lower the number, the better the outcome.

Time frame:
24-hours post operatively and 48-hours post operatively
Reported as:
Mean · units on a scale
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
units on a scaleReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
24-hours post-op47.9 (43.4 to 52.4)49.6 (45.1 to 54.1)
48-hours post-op44.2 (39.7 to 48.8)45.9 (41.4 to 50.5)
SecondaryPresence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)

The presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.

Time frame:
24 hours post operavtively
Reported as:
Number · participants
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
participantsReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
Any post-op nausea and/or vomiting, or itching, yes6862
Post-Op nausea, yes2127
Post-op vomiting, yes1112
Pruritis, yes6058
SecondaryOverall Patient Satisfaction With Pain Control

Patients were asked to mark their satisfaction with pain control using a Visual Analog Scale (VAS) from 0-100. The higher the number, the more satisfied they were with the post-op pain control

Time frame:
48 hours post-op
Reported as:
Median · units on a scale
Overall Patient Satisfaction With Pain Control
units on a scaleReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
Overall Patient Satisfaction With Pain Control93.75 (75 to 100)94.5 (75 to 100)

Adverse events

Collected over Adverse event data was collected from randomization through 48-hours postoperatively.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Receiving 0.1 mg IT Morphine0/101 (0%)0/101 (0%)68/101 (67.3%)
Recieving 0.05 mg IT Morphine0/100 (0%)0/100 (0%)62/100 (62%)
Most frequent other events
Most frequent other events
EventReceiving 0.1 mg IT MorphineRecieving 0.05 mg IT Morphine
PruritisSkin and subcutaneous tissue disorders60/10158/100
Post-Op NauseaGastrointestinal disorders21/10127/100
Post-Op VomitingGastrointestinal disorders11/10112/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)Receiving 0.1 mg IT MorphineRecieving 0.05 mg IT MorphineTotal
Mean31.4 ± 5.1931.7 ± 6.0731.6 ± 5.65
Sex: Female, Male
Sex: Female, Male(Participants)Receiving 0.1 mg IT MorphineRecieving 0.05 mg IT MorphineTotal
Female101100201
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Receiving 0.1 mg IT MorphineRecieving 0.05 mg IT MorphineTotal
Hispanic or Latino4610
Not Hispanic or Latino9794191
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Receiving 0.1 mg IT MorphineRecieving 0.05 mg IT MorphineTotal
White6861129
Black/African American243155
Other9817
Prior C-Section, yes
Prior C-Section, yes(Participants)Receiving 0.1 mg IT MorphineRecieving 0.05 mg IT MorphineTotal
Count of participants6573138
07

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 28, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03427463
Lead sponsor
Medical University of South Carolina
Responsible party
Katherine Hatter, MD (Assistant Professor, Medical University of South Carolina) — Principal investigator
First posted
Feb 9, 2018
Start date
Jan 16, 2018
Primary completion
Aug 3, 2023
Completion
Aug 3, 2023
Results posted
Dec 19, 2024
Last update
Dec 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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