Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

Not Applicable

Recruiting

• Conditions: Post Operative Pain
• Interventions: Drug: Parecoxib + paracetamol; Drug: Normal saline

• Registration Number: NCT05757388
• Lead Sponsor: Khon Kaen University

Brief Summary

Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. The investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.

Detailed Description

Patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. This may interfere with the daily life of the patients. Proper prophylaxis and management to control postoperative pain are essential. Morphine is the most common drug to control postoperative pain. However, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. Multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. Parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. The investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.

Study Timeline

• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Study Start: 2023-03-28
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients with breast cancer undergoing elective mastectomy
• ASA physical status 1-3

Exclusion Criteria

• Allergy to parecoxib, paracetamol, or sulfonamide
• History of opioid use
• Pregnant
• Renal or hepatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Parecoxib + paracetamol	Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction.
Group C	Normal saline	Receives normal saline in the same process.

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	Up to 24 hours postoperatively	Postoperative morphine requirement

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	Up to 3 months postoperatively	Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement
Quality of life score	Up to 24 hours postoperatively	WHOQOL-BREF-THAI questionair (World Health Organization Quality of Life Brief - Thai: 26-130; higher score means a better outcome)
Postoperative nausea/vomiting score	Up to 24 hours postoperatively	Postoperative nausea/vomiting score (0-3; higher score means a worse score)

Trial Locations

Locations (1)

Dr. Sirirat Tribuddharat; 🇹🇭 Khon Kaen, Thailand