CompletedNCT03198871Updated Jan 28, 2021Results posted

IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population

A Phase 4 interventional study of Acetaminophen Injectable Product and Sodium Chloride 0.9%, Intravenous in Abdominal Wall Hernia, Pancreatic Diseases and Bowel Disease, sponsored by Kathirvel Subramaniam. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Kathirvel Subramaniam · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 180
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).

Read the detailed description

In response to an increased focus on improving patient outcomes and satisfaction with surgical care, a growing body of clinical evidence has recently been dedicated to enhanced recovery after surgery (ERAS) protocols. These evidence-based perioperative pathways aim to optimize patients undergoing surgery in the preoperative, intraoperative, and postoperative periods. ERAS protocols have incorporated the use of multimodal analgesia to minimize the use of intra- and postoperative opioid analgesics. Lidocaine, ketamine, magnesium, gabapentin, acetaminophen and non-steroidal anti-inflammatory drugs are some of the adjuvant analgesics used in combination with regional blocks to optimize analgesia and recovery. Multimodal analgesia has dependably been shown to significantly reduce postoperative opioid requirements as well as opioid-related side effects such as postoperative nausea and vomiting. Both oral and intravenous acetaminophen preparations have been shown to be useful adjuvants in multimodal analgesia. Intravenous acetaminophen has been of interest for its utility in post-surgical patients, who have not yet been cleared for oral intake. Intravenous acetaminophen should also be preferred over oral acetaminophen in patients after major abdominal surgery where absorption of medications given through oral route is erratic. Although the efficacy of intravenous acetaminophen as a postoperative pain adjunct is known, its exact role in ERAS protocols and non-narcotic multimodal analgesic regimens for major abdominal surgery has not been studied in randomized clinical trials to define its efficacy. The primary goal of this study is to assess the utility of a postoperative intravenous acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and opioid-related side effects. We also aim to study overall patient satisfaction and cost-effectiveness (direct and indirect costs) of this regimen as part of ERAS protocol at a large tertiary medical center.

Conditions studied

Abdominal Wall Hernia
Pancreatic Diseases
Bowel Disease
Gastric Disease

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Keywords

Post-operative pain
Major abdominal surgery
Colorectal surgery
Gastric surgery

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male or Female
18 years of age or older
patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
Patient consent will be obtained preoperatively for eligible study participants.

Exclusion criteria

Exclusion Criteria:

Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
Patients with a documented allergy to acetaminophen.
Chronic alcoholism
Hypovolemia
Chronic malnutrition
Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis
Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease
severe chronic pain condition that required daily preoperative opioid dependence
Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 180 participants (actual)

Study arms

Experimental
Acetaminophen Injectable Product
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Drug: Acetaminophen Injectable Product
Placebo comparator
Sodium Chloride 0.9%, Intravenous
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Drug: Sodium Chloride 0.9%, Intravenous

Interventions

DrugAcetaminophen Injectable Product
The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
Also known as: Tylenol, Paracetamol, Ofirmev
DrugSodium Chloride 0.9%, Intravenous
The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
Also known as: Saline

What researchers measure

Primary outcomes

Postoperative Pain Intensity
Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.
Time frame: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.

Secondary outcomes

Total Post-operative Narcotic Consumption
Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.
Time frame: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first
Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
The time from PACU admission to PACU discharge to the floor will be measured.
Time frame: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
Time to Bowel Movement
The time it takes for the first bowel movement postoperatively will be measured.
Time frame: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
Time to Oral Intake
The time it takes for the patient to ingest orally post-surgery will be measured.
Time frame: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
Time to Ambulation
The time it takes for the patient to successfully ambulate post-surgery will be measured.
Time frame: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
Time to Hospital Discharge
The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.
Time frame: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first
Number of Participants With Readmission to the Hospital
If the patient is readmitted to the hospital after being fully discharged, the event will be recorded.
Time frame: From the time of consent until 30 days post-operatively
Patient Satisfaction
Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction.
Time frame: These measurements will be taken at time of discharge up to 30 days, whichever comes first
Intensive Care Delirium Screening Checklist (ICDSC)
Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium.
Time frame: The delirium scores will first be measured every 12 hours for 72 hours after surgery.
Post-operative Nausea
Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.
Time frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Post-operative Emesis
Frequency of emesis and rescue antiemetic requirement will be documented
Time frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
SF-12 Health Survey
Survey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Time frame: These measurements will take place at 30-days post hospital discharge

Results

Posted Jan 28, 2021

Participant flow

Participant flow — Overall Study
Milestone	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Started	90	90
Completed	76	78
Not completed	14	12

Outcome measures

PrimaryPostoperative Pain Intensity

Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.

Time frame:: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.
Reported as:: Count of participants · Participants

Postoperative Pain Intensity
Participants	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Postoperative Pain Intensity	33	42

SecondaryTotal Post-operative Narcotic Consumption

Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.

Time frame:: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first
Reported as:: Median · mg

Total Post-operative Narcotic Consumption
mg	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
0-24 hours	27.4 (10 to 49)	36 (17.5 to 85)
24-48 hours	31.3 (7.5 to 73.3)	45 (15 to 95)
48-72 hours	30 (0 to 70)	37.5 (0 to 70)
0-48 hours	74 (25.5 to 113)	88.8 (42.5 to 167.5)
0-72 hours	105.00 (41.3 to 186.3)	127.1 (49.3 to 252.00)

SecondaryTime to Readiness for Discharge From Post Anesthesia Care Unit (PACU)

The time from PACU admission to PACU discharge to the floor will be measured.

Time frame:: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
Reported as:: Median · minutes

Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
minutes	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)	129.00 (106 to 186)	152.50 (98.50 to 208.50)

SecondaryTime to Bowel Movement

The time it takes for the first bowel movement postoperatively will be measured.

Time frame:: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
Reported as:: Median · hours

Time to Bowel Movement
hours	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Time to Bowel Movement	46.30 (25.38 to 90.85)	64.66 (29.27 to 115.33)

SecondaryTime to Oral Intake

The time it takes for the patient to ingest orally post-surgery will be measured.

Time frame:: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
Reported as:: Median · hours

Time to Oral Intake
hours	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Time to Oral Intake	12.15 (4.53 to 33.17)	9.40 (3.87 to 43.38)

SecondaryTime to Ambulation

The time it takes for the patient to successfully ambulate post-surgery will be measured.

Time frame:: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
Reported as:: Median · hours

Time to Ambulation
hours	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Time to Ambulation	18.82 (4.42 to 37.77)	17.38 (4.28 to 22.65)

SecondaryTime to Hospital Discharge

The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.

Time frame:: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first
Reported as:: Median · days

Time to Hospital Discharge
days	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Time to Hospital Discharge	4.08 (3.07 to 6.04)	4.94 (3.94 to 7.12)

SecondaryNumber of Participants With Readmission to the Hospital

If the patient is readmitted to the hospital after being fully discharged, the event will be recorded.

Time frame:: From the time of consent until 30 days post-operatively
Reported as:: Count of participants · Participants

Number of Participants With Readmission to the Hospital
Participants	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Number of Participants With Readmission to the Hospital	9	10

SecondaryPatient Satisfaction

Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction.

Time frame:: These measurements will be taken at time of discharge up to 30 days, whichever comes first
Reported as:: Median · score on a scale

Patient Satisfaction
score on a scale	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Patient satisfaction score, overall	10 (9 to 10)	10 (9 to 10)
Patient Satisfaction score, pain management	10 (9 to 10)	10 (8 to 10)

SecondaryIntensive Care Delirium Screening Checklist (ICDSC)

Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium.

Time frame:: The delirium scores will first be measured every 12 hours for 72 hours after surgery.
Reported as:: Count of participants · Participants

Intensive Care Delirium Screening Checklist (ICDSC)
Participants	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Intensive Care Delirium Screening Checklist (ICDSC)	0	0

SecondaryPost-operative Nausea

Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.

Time frame:: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Reported as:: Mean · score on a scale

Post-operative Nausea
score on a scale	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Nausea score POD 1 (am visit)	1.13 ± 2.82	0.60 ± 1.76
Nausea score POD 1 (pm visit)	0.49 ± 1.54	0.92 ± 2.53
Nausea score POD 2 (am visit)	0.71 ± 1.97	0.75 ± 2.39
Nausea score POD 2 (pm visit)	0.55 ± 1.70	0.69 ± 2.36
Nausea score POD 3 (am visit)	0.32 ± 1.37	0.66 ± 2.18
Nausea score POD 3 (pm visit)	0.56 ± 1.77	0.78 ± 2.42

SecondaryPost-operative Emesis

Frequency of emesis and rescue antiemetic requirement will be documented

Time frame:: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Reported as:: Count of participants · Participants

Post-operative Emesis
Participants	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Emesis incidence 0-72 hours	12	14
Antiemetic use	31	45

SecondarySF-12 Health Survey

Survey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

Time frame:: These measurements will take place at 30-days post hospital discharge
Reported as:: Median · Z-scores (difference compared to the pop

SF-12 Health Survey
Z-scores (difference compared to the pop	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
SF 12 Physical score	38.72 (30.73 to 43.28)	38.07 (32.56 to 45.85)
SF 12 Mental score	54.02 (48.33 to 57.42)	52.08 (42.66 to 57.88)

Adverse events

Collected over 30 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Acetaminophen Injectable Product	0/76 (0%)	3/76 (3.9%)	8/76 (10.5%)
Sodium Chloride 0.9%, Intravenous	0/78 (0%)	3/78 (3.8%)	8/78 (10.3%)

Most frequent serious events

Most frequent serious events
Event	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Acute Kidney InjuryRenal and urinary disorders	2/76	1/78
Respiratory DepressionRespiratory, thoracic and mediastinal disorders	1/76	1/78
PnemoniaRespiratory, thoracic and mediastinal disorders	0/76	1/78

Most frequent other events

Most frequent other events
Event	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous
Urinary RetentionRenal and urinary disorders	2/76	3/78
PruritisSkin and subcutaneous tissue disorders	2/76	0/78
Anastomotic LeakSurgical and medical procedures	2/76	2/78
Prolonged IleusGastrointestinal disorders	1/76	2/78
Respiratory DepressionRespiratory, thoracic and mediastinal disorders	1/76	0/78
Pancreatic LeakSurgical and medical procedures	0/76	1/78

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
Median	62 (55 to 70.75)	64 (53.75 to 74)	63 (52.25 to 72.75)

Sex: Female, Male
Sex: Female, Male(Participants)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
Female	40	44	84
Male	36	34	70

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	4	2	6
White	70	73	143
More than one race	0	0	0
Unknown or Not Reported	2	2	4

Region of Enrollment
Region of Enrollment(participants)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
United States	76	78	154

Basal Metabolic Index
Basal Metabolic Index(kg/m^2)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
Median	27.7 (24.4 to 32.55)	28.25 (23.8 to 32.4)	28.15 (23.86 to 32.4)

Charlson Comorbidity Index
Charlson Comorbidity Index(Participants)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
0	44	41	85
1	4	10	14
2	23	24	47
>2	5	3	8

American Society of Anesthesiologists Classification
American Society of Anesthesiologists Classification(Participants)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
II	17	18	35
III	57	55	112
IV	2	5	7

Number of participants taking medications for mental health
Number of participants taking medications for mental health(Participants)	Acetaminophen Injectable Product	Sodium Chloride 0.9%, Intravenous	Total
Count of participants	15	27	42

8 further baseline measures are reported on the registry.

Study locations

1 site

Upmc Presbyterian Montefiore Hospital
Pittsburgh, Pennsylvania 15213, United States

References and documents

Publications

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Study documents

Protocol and statistical analysis plan · Jun 5, 2019

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

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03198871
Lead sponsor: Kathirvel Subramaniam
Collaborators: Mallinckrodt
Responsible party: Kathirvel Subramaniam (Principal Investigator, Associate Professor, University of Pittsburgh) — Sponsor-investigator
First posted: Jun 26, 2017
Start date: May 24, 2018
Primary completion: Jul 7, 2019
Completion: Nov 30, 2020
Results posted: Jan 28, 2021
Last update: Jan 28, 2021

Study contacts

Kathirvel Subramaniam, M.D., M.P.H

principal investigator · Associate Professor and staff Anesthesiologist

Oversight

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

View the source record on ClinicalTrials.gov ↗

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