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

NCT ID: NCT05509244

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control group

acetaminophen 1g iv dripping

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

acetaminophen 1g iv dripping at end of surgery

experimental group

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

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

acetaminophen 1g iv dripping at end of surgery

Ibuprofen

Intervention Type DRUG

ibuprofen 300mg iv dripping at end of surgery

Interventions

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Acetaminophen

acetaminophen 1g iv dripping at end of surgery

Intervention Type DRUG

Ibuprofen

ibuprofen 300mg iv dripping at end of surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Young Eun Moon

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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youngeun moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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youngeun moon, MD, PhD

Role: CONTACT

822-2258-6163

jungmin gu, MD

Role: CONTACT

822-2258-6163

Facility Contacts

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Young Eun Moon, Md, PhD

Role: primary

Other Identifiers

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acetaminophen-ibuprofen

Identifier Type: -

Identifier Source: org_study_id

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