Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

January 7, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital

Additive Effect of Intravenous Acetaminophen Administered at the End of Surgery on Postoperative Pain Control With Nefopam and Fentanyl-based Patient-controlled Analgesia: A Double-blind Randomized Controlled Trial

This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.

Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

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

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

15 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse

Exclusion Criteria:

  • Liver disease (aspartate transaminase OR alanine transaminase > 80 IU/L)
  • Chronic kidney disease (GFR < 30 ml/min/1.73m2)
  • History of drug allergy
  • Chronic pain lasting more than 3 months
  • Conversion to laparotomy
  • Complex surgery (co-operation with colon surgeon or urologist)
  • Limitation in expressing pain

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: Treatment
Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.
Drug: Acetaminophen
Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
Other Names:
  • treatment
No Intervention: Control
Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume of administered analgesics during postoperative 24 hours
Time Frame: 24 hours
morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 24 hours
11-point numeric rating scale ranging from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
24 hours
Patient satisfaction score
Time Frame: 24 hours
11-point numeric rating scale ranging from '0' representing one extreme (e.g. "extremely dissatisfied") to '10' representing the other extreme (e.g. "extremely satisfied")
24 hours
Postoperative nausea and vomiting
Time Frame: 24 hours
4-scales scoring (none; mild; moderate; severe)
24 hours
Opioid-related adverse effect
Time Frame: 24 hours
Incidence of respiratory, gastrointestinal, and central nervous system complications
24 hours
Use of alternative analgesics
Time Frame: 24 hours
Additional administration of other analgesics
24 hours
Length of stay
Time Frame: From date of hospital admission until the date of discharge, an average of 1 week
Hospital length of stay
From date of hospital admission until the date of discharge, an average of 1 week

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

August 27, 2018

Primary Completion (Actual)

January 6, 2021

Study Completion (Actual)

January 7, 2021

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1807-151-961

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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