Phase 4
N=180
IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
Abdominal Wall Hernia · Pancreatic Diseases · Bowel Disease · Gastric Disease
Bottom Line
View on ClinicalTrials.gov: NCT03198871 ↗Enrolled (actual)
180
Serious AEs
3.9%
Results posted
Jan 2021
Primary outcome: Primary: Postoperative Pain Intensity — 33; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen Injectable Product (Drug); Sodium Chloride 0.9%, Intravenous (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kathirvel Subramaniam
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Intensity |
33; 42 | — |
| SECONDARY Total Post-operative Narcotic Consumption |
27.4; 36; 31.3; 45; 30; 37.5 | — |
| SECONDARY Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU) |
129.00; 152.50 | — |
| SECONDARY Time to Bowel Movement |
46.30; 64.66 | — |
| SECONDARY Time to Oral Intake |
12.15; 9.40 | — |
| SECONDARY Time to Ambulation |
18.82; 17.38 | — |
| SECONDARY Time to Hospital Discharge |
4.08; 4.94 | — |
| SECONDARY Number of Participants With Readmission to the Hospital |
9; 10 | — |
| SECONDARY Patient Satisfaction |
10; 10; 10; 10 | — |
| SECONDARY Intensive Care Delirium Screening Checklist (ICDSC) |
0; 0 | — |
| SECONDARY Post-operative Nausea |
1.13; 0.60; 0.49; 0.92; 0.71; 0.75 | — |
| SECONDARY Post-operative Emesis |
12; 14; 31; 45 | — |
| SECONDARY SF-12 Health Survey |
38.72; 38.07; 54.02; 52.08 | — |
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).
Eligibility Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03198871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.