NCT05509244

Brief Summary

Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after laparoscopic gynecologic surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

August 17, 2022

Last Update Submit

September 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    the maximal postoperative pain severity using pain scale (0=no pain; 10=the worst pain)

    during 30 minutes after surgery

Study Arms (2)

control group

ACTIVE COMPARATOR

acetaminophen 1g iv dripping

Drug: Acetaminophen

experimental group

EXPERIMENTAL

the combination of acetaminophen 1g and ibuprofen 300mg iv dripping

Drug: AcetaminophenDrug: Ibuprofen

Interventions

acetaminophen 1g iv dripping at end of surgery

control groupexperimental group

ibuprofen 300mg iv dripping at end of surgery

experimental group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled gynecologic laparoscopic surgery

You may not qualify if:

  • Refusal to be enrolled in the study
  • Emergency surgery
  • On chronic pain medications
  • Psychiatric disorders
  • Pregnant, lactating women
  • Allergy or contraindication to the medication drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 07651, South Korea

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • youngeun moon, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

youngeun moon, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 22, 2022

Study Start

September 9, 2022

Primary Completion

August 24, 2023

Study Completion

August 31, 2023

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations