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
About this trial
This is an interventional treatment trial for Gynecologic Disease
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
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
NCT ID
NCT05509244
First Posted
August 17, 2022
Last Updated
September 22, 2022
Sponsor
The Catholic University of Korea
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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