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Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery

Primary Purpose

Gynecologic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acetaminophen
Ibuprofen
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled gynecologic laparoscopic surgery

Exclusion Criteria:

  1. Refusal to be enrolled in the study
  2. Emergency surgery
  3. On chronic pain medications
  4. Psychiatric disorders
  5. Pregnant, lactating women
  6. Allergy or contraindication to the medication drugs

Sites / Locations

  • Seoul St.Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

experimental group

Arm Description

acetaminophen 1g iv dripping

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 17, 2022
Last Updated
September 22, 2022
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05509244
Brief Title
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
Official Title
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
August 24, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after laparoscopic gynecologic surgery. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
acetaminophen 1g iv dripping
Arm Title
experimental group
Arm Type
Experimental
Arm Description
the combination of acetaminophen 1g and ibuprofen 300mg iv dripping
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
acetaminophen 1g iv dripping at end of surgery
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
ibuprofen 300mg iv dripping at end of surgery
Primary Outcome Measure Information:
Title
postoperative pain
Description
the maximal postoperative pain severity using pain scale (0=no pain; 10=the worst pain)
Time Frame
during 30 minutes after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled gynecologic laparoscopic surgery Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
youngeun moon, MD, PhD
Phone
822-2258-6163
Email
0910momo@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
jungmin gu, MD
Phone
822-2258-6163
Email
cmcanepm@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
youngeun moon, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
07651
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Eun Moon, Md, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery

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