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

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05509244
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.2
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Disease	Drug: Acetaminophen; Drug: Ibuprofen	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
• Anticipated Study Start Date: Aug 24, 2022
• Anticipated Primary Completion Date: Aug 24, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group acetaminophen 1g iv dripping	Drug: Acetaminophen; acetaminophen 1g iv dripping at end of surgery
Experimental: experimental group the combination of acetaminophen 1g and ibuprofen 300mg iv dripping	Drug: Acetaminophen; acetaminophen 1g iv dripping at end of surgery; Drug: Ibuprofen; ibuprofen 300mg iv dripping at end of surgery

Outcome Measures

Primary Outcome Measures

1. postoperative pain [during 30 minutes after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St.Mary's Hospital	Seoul	Seocho-gu	Korea, Republic of	07651

Sponsors and Collaborators

• The Catholic University of Korea

Investigators

• Principal Investigator: youngeun moon, MD, PhD, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Eun Moon, professor, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT05509244
• Other Study ID Numbers: acetaminophen-ibuprofen
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen; Ibuprofen

Study Results

No Results Posted as of Aug 22, 2022