Breast Exicision Biopsy
Conditions
Keywords
Randomised control trial, parecoxib, Breast excision biopsy
Brief summary
The goal of this clinical trial is to learn if generic parecoxib (Parestat) works as well as the original drug (Dynastat) for treating pain after breast surgery. It will also learn about the safety of both drugs. The main questions it aims to answer are: * Does Parestat provide pain relief that is not inferior to the pain relief provided by Dynastat? * What medical problems (adverse events) do participants have when taking Parestat compared to Dynastat? Researchers will compare Parestat to Dynastat to see if the generic version also works to treat postoperative pain. Participants will: * Be randomly assigned to receive either Dynastat or Parestat during their surgery. * Have their pain level assessed using the Visual Analog Scale (VAS) upon arrival in the recovery bay, 6 and 24 hours after surgery. * Be monitored for common side effects like nausea, vomiting, and changes in blood pressure for 24 hours.
Detailed description
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.
Interventions
DRUGParestat(generic parecoxib)
This arm will receive IV Parestat 40mg during surgery
DRUGDynastat (original Parecoxib)
This arm will receive IV Dynastat 40mg during surgery
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactAhmad Fariz Elias
Outcome results
None listed