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

Rajavithi Hospital

Status and phase

Completed

Phase 4

Conditions

Postoperative Pain

Gynecological Surgery

Parecoxib

Preemptive Analgesia

Treatments

Drug: Normal saline

Drug: Parecoxib

Study type

Interventional

Funder types

Other

Identifiers

NCT06140238

113/2566

Details and patient eligibility

About

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

Full 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

Enrollment

178 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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