Study Comparing Dynastat and Parestat Pain Relief Medications for Patients After Breast Surgery

The goal of this clinical trial is to determine whether generic parecoxib (Parestat) is as effective as the original parecoxib (Dynastat) for treating pain following breast surgery. The trial will also assess the safety of both medications. The main questions it aims to answer are:

1. Does generic parecoxib (Parestat) provide the same level of pain relief as original parecoxib (Dynastat) after breast biopsy surgery?
2. What side effects do participants experience when taking either medication?

Researchers will compare Parestat to Dynastat to see if the generic version is equally effective for managing postoperative pain.

Participants in the study will:

* Receive either Parestat or Dynastat during their breast excision biopsy surgery.
* Have their pain levels measured using a pain scale at three time points: in the recovery room, before transferring to the ward, and 24 hours after surgery.
* Be monitored for side effects such as nausea, changes in blood pressure, swelling, and other adverse reactions for 24 hours.
* Be kept unaware of which medication they received (double-blind study design).

The study will involve 60 adult women undergoing elective breast biopsy surgery, with 30 participants in each treatment group.t group.

• Parestat(generic parecoxib) (Drug): This arm will receive IV Parestat 40mg during surgery
• Dynastat (original Parecoxib) (Drug): This arm will receive IV Dynastat 40mg during surgery

Primary outcomes

• Pain Score [24 hours after surgery completed]: Each participant's pain score will be assessed using the Numeric Rating Scale (NRS) at three time points: upon arrival in the recovery bay, before discharge from the recovery bay, and 24 hours postoperatively. The NRS ranges 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Highest score reflect worst outcome

Secondary outcomes

• Adverse events [24 hours after completion of surgery]: To detect and compare the incidence of common adverse events between the two groups, specifically: * Nausea and vomiting, constipation * Changes in blood pressure, differences 20% from baseline (increase or decrease) * Edema * Pruritus * Gastritis * Bronchospasm

Sex: Female, ages: 18 Years to 65 Years

Inclusion Criteria:

Patients aged 18 years or older. Patients scheduled for elective excision biopsy of the breast. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I or II.

Patients who can understand and provide written informed consent.

Exclusion Criteria:

Patients with a known allergy or contraindication to parecoxib or any of its excipients.

Patients with a history of severe gastrointestinal bleeding, ulceration, or perforation.

Patients with a history of significant cardiovascular disease (e.g., unstable angina, recent myocardial infarction, stroke).

Patients with uncontrolled hypertension. Patients with severe renal impairment (creatinine clearance < 30 mL/min). Patients with severe hepatic impairment (Child-Pugh Class C). Patients who are pregnant or breastfeeding. Patients taking medications that are contraindicated with parecoxib (refer to drug interaction section).

Patients with a history of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

• Ahmad Fariz Elias, Principal investigator, University of Malaya