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Completed

NCT Number: NCT06140238

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rajavithi Hospital

Bangkok, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parecoxib

Drug

Parecoxib administration 15 minutes before start surgical operation

normal saline

Drug

Normal saline administration 15 minutes before start surgical operation

Primary outcomes

  1. Post operative pain score

    Time frame: 24 hour post operation

    Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale'

Secondary outcomes

  1. Total dose of opioid drug consumption

    Time frame: 24 hour post operation

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

Other outcomes

  1. Side effect from Parecoxib drug

    Time frame: 24 hour post operation

    observe any side effects of Parecoxib drug which are nausea, vomit and respiratory depression

  2. Total hospital length stay after operation

    Time frame: Post operation date to discharge date

    record total hospital length stay since post operation date to discharge date

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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