Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological Surgery

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-06-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The research is to test the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery by comparing Parecoxib drug and NSS administration 15 min before starting the surgery which the result of postoperative pain score is interpret by visual analog scale index

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery

NCT01566669

Benign Female Reproductive System Neoplasm

COMPLETED NA

Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain

NCT00143169

Pain, Postoperative

COMPLETED PHASE3

Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

NCT05757388

Post Operative Pain

UNKNOWN NA

Parecoxib vs. Dexketoprofen for the Management of Pain After Cesarean Section.

NCT04847024

Caesarean Section; Pain

COMPLETED NA

Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation

NCT00435747

Pain, Postoperative

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The research is working on testing the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery whether its can reduce postoperative pain score, reduce total opioid consumption in first 24 hour postoperation and reduce postoperation hospital length stay. Patients who are undergoing gynecological surgery is recruited to the research project while they admit in the hospital for preoperative preparation, in each type of surgery groups (1.Total abdominal hysterectomy 2. Adnexal surgery 3. Surgical staging) will divided in to 2 groups which is experimental group (Parecoxib) and control group (Normal saline). The experimental group will have Parecoxib administration 15 min before starting the surgery and control group will have normal saline administration 15 min before starting the surgery as same, the primary result is postoperative pain score which is interpreted by Visual analog scale index at 2,6,12,24 hour postoperation, the patients will get opioid drug (Morphine) for pain control depending on pain score index they inform, if pain score \>7: morphine 0.075 mg/kg iv, if pain score 5 : morphine 0.05mg/kg iv, if pain score \<5 : no morphine given. Lastly the side effect of Parecoxib drug will be observed and postoperative hospital length stay of each patient will be recorded

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preemptive Analgesia Gynecological Surgery Postoperative Pain Parecoxib

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Groups of patients who have Parecoxib drug administration before start surgery

Group Type EXPERIMENTAL

Parecoxib

Intervention Type DRUG

Parecoxib administration 15 minutes before start surgical operation

Control group

Group of patients who have normal saline (Placebo) administration before start surgery

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline administration 15 minutes before start surgical operation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parecoxib

Parecoxib administration 15 minutes before start surgical operation

Intervention Type DRUG

Normal saline

Normal saline administration 15 minutes before start surgical operation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patients age between 18-70 year-old, who participate in explor lap gynecological surgery (Hysterectomy, Adnexal surgery and surgical stagings) using general anesthesia technique
* American society of Anesthesiologists physical status grade I-II
* Capable to communicate in Thai language

Exclusion Criteria

* Allergic to NSAIDs and opioid
* Allergic to Parecoxib drug
* Underlying neuropathic pain
* Pregnant woman or woman who undergoes breast feeding
* Uncontrolled hypertension disease, BP \>160/110 at admission date
* Underlying ischemic heart disease, Ischemic stroke or peripheral arterial disease
* History status post coronary artery bypass grafting
* Patients who take Aspirin within 7 days before surgery date
* Had underlying which is contraindiated to NSAIDs drug such as Gastritis, history of GI ulcer, chronic kidney disease (Cr clearance \< 30ml/min), liver cirrhosis (Child-Pugh class B or above/ serum albumin \< 25 g/l)
* Patients who had NSAIDs drug while admit in hospital for preparing the operation before surgery date

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes