Dynastat vs. Parestat for Postoperative Analgesia in Breast Surgery: A Non-Inferiority Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain Score
研究概览
简要总结
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.
详细描述
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:
- Does generic parecoxib (Parestat) provide the same level of pain relief as original parecoxib (Dynastat) after breast biopsy surgery?
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Parestat Group, Parestat(generic parecoxib)
Patients receiving IV Parestat 40mg (generic Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision.
干预措施: Parestat(generic parecoxib) (Drug)
Dynastat group, Dynastat(Original Parecoxib)
Patients receiving IV Dynastat 40mg (original Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision.
干预措施: Dynastat (original Parecoxib) (Drug)
结局指标
主要结局
Pain Score
时间窗: 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
次要结局
- Adverse events(24 hours after completion of surgery)
研究者
Ahmad Fariz Bin Elias
Dr
University of Malaya