Efficacy of Acetaminophen-ibuprofen Combination on the Po... | NCT05509244

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

NCT05509244

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Sep 26, 2022Actual

Enrollment

64Estimated

Phase

Not Applicable

Conditions

Gynecologic Disease

Interventions

Acetaminophen
Ibuprofen

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2022Actual

Primary Completion Date

Aug 24, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Aug 17, 2022

First Submission Date that Met QC Criteria

Aug 18, 2022

First Posted Date

Aug 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2022

Last Update Posted Date

Sep 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young Eun Moon, professor, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator	acetaminophen 1g iv dripping	Drug: Acetaminophen
experimental group	Experimental	the combination of acetaminophen 1g and ibuprofen 300mg iv dripping	Drug: Acetaminophen Drug: Ibuprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetaminophen	Drug	acetaminophen 1g iv dripping at end of surgery	control group experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pain	the maximal postoperative pain severity using pain scale (0=no pain; 10=the worst pain)	during 30 minutes after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
youngeun moon, MD, PhD	Contact	822-2258-6163		0910momo@naver.com
jungmin gu, MD	Contact	822-2258-6163		cmcanepm@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
youngeun moon, MD, PhD	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St.Mary's Hospital	Recruiting	Seoul	Seocho-gu	07651	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005831	Genital Diseases, Female

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D007052	Ibuprofen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided