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

Postoperative Pain Clinical Trial

Official title:

Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140238
• Other study ID #: 113/2566
• Status: Recruiting
• Phase: Phase 4
• Start date: September 10, 2023
• Est. completion date: June 27, 2024

Study information

• Verified date: August 2023
• Source: Rajavithi Hospital
• Contact: Pasu Tuangjaruwinai, M.D.
• Phone: 092-9949759
• Email: nowpasu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: June 27, 2024
• Est. primary completion date: April 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecological Surgery
• Pain, Postoperative
• Parecoxib
• Postoperative Pain
• Preemptive Analgesia

Intervention

Drug:
• Parecoxib
Parecoxib administration 15 minutes before start surgical operation
• Normal saline
Normal saline administration 15 minutes before start surgical operation

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effect from Parecoxib drug	observe any side effects of Parecoxib drug which are nausea, vomit and respiratory depression	24 hour post operation
Other	Total hospital length stay after operation	record total hospital length stay since post operation date to discharge date	Post operation date to discharge date
Primary	Post operative pain score	Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale'	24 hour post operation
Secondary	Total dose of opioid drug consumption	Total dose of opioid drug consumption (Morphine) in 24 hour post operation	24 hour post operation