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

NCT03198871 | Completed Phase 4 Results FDA Drug

• 1 other identifier: PRO17050418
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Abdominal Wall Hernia; Pancreatic Diseases; Bowel Disease; Gastric Disease

Keywords

Post-operative pain; Major abdominal surgery; Colorectal surgery; Gastric surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (12)

• Total Post-operative Narcotic Consumption

  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)

  From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively

• Time to Bowel Movement

  From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge

• Time to Oral Intake

  From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively

• Time to Ambulation

  From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively

Study Arms (2)

Acetaminophen Injectable Product

EXPERIMENTAL

Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group

Drug: Acetaminophen Injectable Product

Sodium Chloride 0.9%, Intravenous

PLACEBO COMPARATOR

Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group

Drug: Sodium Chloride 0.9%, Intravenous

Interventions

Acetaminophen Injectable Product DRUG

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

Acetaminophen Injectable Product

Sodium Chloride 0.9%, Intravenous DRUG

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

Sodium Chloride 0.9%, Intravenous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kathirvel Subramaniam: lead
• Mallinckrodt: collaborator

Study Sites (1)

Upmc Presbyterian Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (32)

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  PMID: 34498068 DERIVED

MeSH Terms

Conditions

Hernia, Abdominal; Pancreatic Diseases; Intestinal Diseases; Stomach Diseases; Pain, Postoperative

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Kathirvel Subramaniam MD MPH FASE
• Organization: University of Pittsburgh School of Medicine / UPMC

subramaniamk@upmc.edu

7247995852

Study Officials

• Kathirvel Subramaniam, M.D., M.P.H

  Associate Professor and staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider, outcomes assessor and investigator are all blinded to the treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 26, 2017
• Study Start: May 24, 2018
• Primary Completion: July 7, 2019
• Study Completion: November 30, 2020
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)