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

Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Preemptive Analgesia; Parecoxib; Gynecological Surgery
• Intervention / Treatment: Drug: Parecoxib; Drug: Normal saline

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 Type: Interventional
• Enrollment (Estimated): 178
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pasu Tuangjaruwinai, M.D.; Phone Number: 092-9949759; Email: nowpasu@gmail.com
• Study Contact Backup: Name: Siriporn thitisakulwong, M.D.; Phone Number: 092-9536223; Email: heroinsiporn@yahoo.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Rajavithi Hospital
    • Contact: Pasu Tuangjaruwinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Groups of patients who have Parecoxib drug administration before start surgery	Drug: Parecoxib; Parecoxib administration 15 minutes before start surgical operation
Placebo Comparator: Control group; Group of patients who have normal saline (Placebo) administration before start surgery	Drug: Normal saline; Normal saline administration 15 minutes before start surgical operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of opioid drug consumption	Total dose of opioid drug consumption (Morphine) in 24 hour post operation	24 hour post operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effect from Parecoxib drug	observe any side effects of Parecoxib drug which are nausea, vomit and respiratory depression	24 hour post operation
Total hospital length stay after operation	record total hospital length stay since post operation date to discharge date	Post operation date to discharge date

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Estimated): April 27, 2024
• Study Completion (Estimated): June 27, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative pain; Parecoxib; Preemptive analgesia; Gynecological surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: 113/2566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
• IPD Sharing Time Frame: 10 September 2023 to 27 June 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No