Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

NCT ID: NCT03644147

Last Updated: 2021-01-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2021-01-07

Brief Summary

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This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.

Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.

Detailed Description

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Conditions

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Postoperative Pain Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen will be intravenously administrated to treatment group after the end of surgery.

Control

Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acetaminophen

Acetaminophen will be intravenously administrated to treatment group after the end of surgery.

Intervention Type DRUG

Other Intervention Names

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treatment

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse

Exclusion Criteria

* Liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L)
* Chronic kidney disease (GFR \< 30 ml/min/1.73m2)
* History of drug allergy
* Chronic pain lasting more than 3 months
* Conversion to laparotomy
* Complex surgery (co-operation with colon surgeon or urologist)
* Limitation in expressing pain
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, Pf.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Nam S, Yoo S, Park SK, Kim JT. Additive effect of a single intravenous dose of acetaminophen administered at the end of laparoscopic hysterectomy on postoperative pain control with nefopam and fentanyl-based patient-controlled analgesia: a double-blind, randomized controlled trial. BMC Anesthesiol. 2025 Feb 20;25(1):88. doi: 10.1186/s12871-025-02971-w.

Reference Type DERIVED
PMID: 39979845 (View on PubMed)

Other Identifiers

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H-1807-151-961

Identifier Type: -

Identifier Source: org_study_id

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