NCT03644147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 27, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2021

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

August 21, 2018

Last Update Submit

January 7, 2021

Conditions

Postoperative PainGynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • Total volume of administered analgesics during postoperative 24 hours

    morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery

    24 hours

Secondary Outcomes (6)

  • Pain score

    24 hours

  • Patient satisfaction score

    24 hours

  • Postoperative nausea and vomiting

    24 hours

  • Opioid-related adverse effect

    24 hours

  • Use of alternative analgesics

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.

Drug: Acetaminophen

Control

NO INTERVENTION

Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery.

Interventions

AcetaminophenDRUG

Acetaminophen will be intravenously administrated to treatment group after the end of surgery.

Also known as: treatment
Treatment

Eligibility Criteria

Age19 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Nam S, Yoo S, Park SK, Kim JT. Additive effect of a single intravenous dose of acetaminophen administered at the end of laparoscopic hysterectomy on postoperative pain control with nefopam and fentanyl-based patient-controlled analgesia: a double-blind, randomized controlled trial. BMC Anesthesiol. 2025 Feb 20;25(1):88. doi: 10.1186/s12871-025-02971-w.

    PMID: 39979845DERIVED

MeSH Terms

Conditions

Pain, PostoperativeGenital Diseases, Female

Interventions

AcetaminophenTherapeutics

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jin-Tae Kim, Pf.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

August 27, 2018

Primary Completion

January 6, 2021

Study Completion

January 7, 2021

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

KR(1)