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

NCT06140238 | Completed Phase 4 DMC

• 1 other identifier: 113/2566
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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

Conditions

Preemptive Analgesia; Gynecological Surgery; Postoperative Pain; Parecoxib

Keywords

Preemptive analgesia; Gynecological surgery; Parecoxib; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total dose of opioid drug consumption

  24 hour post operation

Other Outcomes (2)

• Side effect from Parecoxib drug

  24 hour post operation

• Total hospital length stay after operation

  Post operation date to discharge date

Study Arms (2)

Experimental group

EXPERIMENTAL

Groups of patients who have Parecoxib drug administration before start surgery

Drug: Parecoxib

Control group

PLACEBO COMPARATOR

Group of patients who have normal saline (Placebo) administration before start surgery

Drug: Normal saline

Interventions

Parecoxib DRUG

Parecoxib administration 15 minutes before start surgical operation

Experimental group

Normal saline DRUG

Normal saline administration 15 minutes before start surgical operation

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxib; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: November 18, 2023
• Study Start: September 10, 2023
• Primary Completion: April 27, 2024
• Study Completion: June 27, 2024
• Last Updated: November 14, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 10 September 2023 to 27 June 2024

Locations

TH (1)