Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Parecoxib + paracetamol
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group P receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction or group C receives the normal saline in the same process.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group P<br>Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction. | Drug: Parecoxib + paracetamol<br>* Administers after induction of anesthesia.<br>* Other names: Study drugs;|
| Placebo Comparator: Group C<br>Receives normal saline in the same process. | Drug: Normal saline<br>* Administers after induction of anesthesia.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine consumption | Postoperative morphine requirement | Up to 24 hours postoperatively | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, multimodal anagesia