Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

Not Applicable

Completed

• Conditions: Postoperative Pain; Gynecologic Disease
• Interventions: Drug: Acetaminophen

• Registration Number: NCT03644147
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Study Start: 2018-08-27
• Status Verified: 2021-01
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-07
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Acetaminophen	Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.

Primary Outcome Measures

Name	Time	Method
Total volume of administered analgesics during postoperative 24 hours	24 hours	morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery

Secondary Outcome Measures

Name	Time	Method
Use of alternative analgesics	24 hours	Additional administration of other analgesics
Length of stay	From date of hospital admission until the date of discharge, an average of 1 week	Hospital length of stay
Opioid-related adverse effect	24 hours	Incidence of respiratory, gastrointestinal, and central nervous system complications
Pain score	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")
Patient satisfaction score	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")
Postoperative nausea and vomiting	24 hours	4-scales scoring (none; mild; moderate; severe)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of