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

Phase 4

Completed

• Conditions: Parecoxib; Preemptive Analgesia; Gynecological Surgery; Postoperative Pain
• Interventions: Drug: Normal saline; Drug: Parecoxib

• Registration Number: NCT06140238
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-28
• Study Start: 2023-09-10
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Primary Completion: 2024-04-27
• Study Completion: 2024-06-27
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	Group of patients who have normal saline (Placebo) administration before start surgery
Experimental group	Parecoxib	Groups of patients who have Parecoxib drug administration before start surgery

Primary Outcome Measures

Name	Time	Method
Post operative pain score	24 hour post operation	Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale'

Secondary Outcome Measures

Name	Time	Method
Total dose of opioid drug consumption	24 hour post operation	Total dose of opioid drug consumption (Morphine) in 24 hour post operation

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand