Clinical trial NCT06140238: Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological Surgery
Official title: Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preemptive Analgesia
Gynecological Surgery
Postoperative Pain
Parecoxib
Keywords: Preemptive analgesia
Gynecological surgery
Parecoxib
Postoperative pain
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pain score
timeFrame: 24 hour post operation
Secondary outcomes:
measure: Total dose of opioid drug consumption
timeFrame: 24 hour post operation
Other outcomes:
measure: Side effect from Parecoxib drug
timeFrame: 24 hour post operation
measure: Total hospital length stay after operation
timeFrame: Post operation date to discharge date
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: