Study Comparing Dynastat and Parestat Pain Relief Medications for Patients After Breast Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parestat(generic parecoxib), Dynastat (original Parecoxib).
- Who it may be relevant to
- Registry conditions: Breast Exicision Biopsy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dynastat vs. Parestat for Postoperative Analgesia in Breast Surgery: A Non-Inferiority Randomised Controlled Trial
Overview
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
- Drug Parestat(generic parecoxib)
This arm will receive IV Parestat 40mg during surgery - Drug Dynastat (original Parecoxib)
This arm will receive IV Dynastat 40mg during surgery
Primary outcome measures
- Pain Score [Time frame: 24 hours after surgery completed]
Secondary outcome measures (1)
- Adverse events [Time frame: 24 hours after completion of surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07154446 · 202557-15040