Skip to main content
OpenTrials
Completed

NCT Number: NCT03198871

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Wall Hernia Bowel Disease Digestive System Diseases Gastric Disease Gastrointestinal Diseases Hernia Hernia, Abdominal Intestinal Diseases Neurologic Manifestations Pain Pain, Postoperative Pancreatic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Upmc Presbyterian Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Tylenol, Paracetamol, Ofirmev

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.

Other names: Saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Kathirvel Subramaniam

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 26, 2017
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.