Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

Khon Kaen University

Status: Enrolling

Conditions: Post Operative Pain

Treatments: Drug: Parecoxib + paracetamol; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05757388

HE641269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Group P

Experimental group

Description:

Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction.

Treatment:

Drug: Parecoxib + paracetamol

Group C

Placebo Comparator group

Description:

Receives normal saline in the same process.

Treatment:

Drug: Normal saline