Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
1 other identifier
interventional
64
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
1 active site
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
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
September 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedSeptember 26, 2022
September 1, 2022
12 months
August 17, 2022
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 COMPARATORacetaminophen 1g iv dripping
experimental group
EXPERIMENTALthe combination of acetaminophen 1g and ibuprofen 300mg iv dripping
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
youngeun moon, MD, PhD
Seoul St. Mary's Hospital
Central Study Contacts
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