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

January 10, 2021 updated by: Kathirvel Subramaniam

Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery After Surgery (ERAS) Population: A Prospective, Randomized, Double-Blind and Placebo-Controlled Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Upmc Presbyterian Montefiore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetaminophen Injectable Product
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Drug: Acetaminophen 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
Other Names:
  • Tylenol
  • Paracetamol
  • Ofirmev
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
The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Post-operative Narcotic Consumption
Time Frame: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first
Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.
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)
Time Frame: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
The time from PACU admission to PACU discharge to the floor will be measured.
From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
Time to Bowel Movement
Time Frame: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
The time it takes for the first bowel movement postoperatively will be measured.
From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
Time to Oral Intake
Time Frame: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
The time it takes for the patient to ingest orally post-surgery will be measured.
From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
Time to Ambulation
Time Frame: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
The time it takes for the patient to successfully ambulate post-surgery will be measured.
From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
Time to Hospital Discharge
Time Frame: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first
The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.
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
Time Frame: From the time of consent until 30 days post-operatively
If the patient is readmitted to the hospital after being fully discharged, the event will be recorded.
From the time of consent until 30 days post-operatively
Patient Satisfaction
Time Frame: These measurements will be taken at time of discharge up to 30 days, whichever comes first
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.
These measurements will be taken at time of discharge up to 30 days, whichever comes first
Intensive Care Delirium Screening Checklist (ICDSC)
Time Frame: The delirium scores will first be measured every 12 hours for 72 hours after surgery.
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.
The delirium scores will first be measured every 12 hours for 72 hours after surgery.
Post-operative Nausea
Time Frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.
These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Post-operative Emesis
Time Frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Frequency of emesis and rescue antiemetic requirement will be documented
These will be evaluated from the time of PACU admission until 72 hours postoperatively.
SF-12 Health Survey
Time Frame: These measurements will take place at 30-days post hospital discharge
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
These measurements will take place at 30-days post hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathirvel Subramaniam

Collaborators

Mallinckrodt

Investigators

  • Principal Investigator: Kathirvel Subramaniam, M.D., M.P.H, Associate Professor and staff Anesthesiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2018

Primary Completion (Actual)

July 7, 2019

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 10, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO17050418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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