Preemptive Analgesia Combination of Celecoxib and Pregabalin in Total Hip Arthroplasty: Comparison of the Effects of Single Dose and Repeated Doses (Double-Blind Randomized Clinical Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Postoperative Pain
研究概览
简要总结
This is a double-blinded randomized controlled trial aims to evaluate the effect of preemptive analgetic combination of celecoxib and pregabalin to acute pain after total hip arthroplasty. This study will be conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, from October 2022 to April 2023. The subject of this study is adult patient who will be performed total hip arthroplasty.
详细描述
- Research design This is a double-blind, randomized clinical trial which aimed to evaluate the effect of preemptive analgesia combined with Celecoxib and Pregabalin on acute post-THA pain.
- Study location This study will be conducted at the Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
- Study time This study will be conducted in October 2022 - April 2023
- Population and sample The target population of this study is adult patients undergoing THA surgery. The randomization technique used in this study is a simple randomization technique. Researchers randomly determine the allocation of samples without looking at subjects' status in the population.
- Inclusion criteria
- Patients >18 years old
- Patients who come to the RSCM Orthopedic Polyclinic
- Patients undergoing THA surgery
- Patients with Primary and Secondary Pelvic Osteoarthritis
- The patient is taking anti-pain and anti-inflammatory drugs regularly
- Exclusion criteria
- Patients with mental disorders
- Patients with a history of renal impairment
- Pelvic arthritis patients due to rheumatoid arthritis or infection
- Patients with diabetes and obesity
- Allergy to non-steroidal inflammatory drugs
- Asthma history
- Coagulation disorders
- Patients in the study procedure experienced an incident of severe pain that required another analgesic regimen
- History of hypersensitivity to NSAIDs or sulfonamides
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, Investigator)
盲法说明
Randomization performed by simple random sampling, the result is latern given to investigator in an envelope containing codes made by third party outside the research. Investigator and the patient do not know the allocation code
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years old
- •Patients who come to the RSCM Orthopedic Polyclinic
- •Patients undergoing THA operasi surgery
- •Patients with Primary and Secondary Pelvic Osteoarthritis
- •The patient is taking anti-pain and anti-inflammatory drugs regularly
排除标准
- •Patients with mental disorders
- •Patients with a history of renal impairment
- •Pelvic arthritis patients due to rheumatoid arthritis or infection
- •Patients with diabetes and obesity
- •Allergy to non-steroidal inflammatory drugs
- •Asthma history
- •Coagulation disorders
研究组 & 干预措施
Single dose of celecoxib 400 mg and pregabalin 150 mg
Single dose of celecoxib 400 mg and pregabalin 150 mg administered an hour before surgery
干预措施: Single dose of celecoxib 400 mg and pregabalin 150 mg (Drug)
Repeated dose of celecoxib 200 mg and pregabalin 75 mg
Repeated dose of celecoxib 200 mg twice a day and pregabalin 75 mg twice a day administered starting from 3 days before surgery
干预措施: Repeated dose of celecoxib 200 mg and pregabalin 75 mg (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: After surgery for three days
Acute pain measured in the morning before activity after surgery. Measured by numeric pain rating scale 0 - 10 which lower score means less pain while higher score means more pain
Total consumption of morphine
时间窗: Three days
Morphine is an opioid analgesic, in this study it was used as an analgesic as well as an objective parameter to assess the effectiveness of celecoxib and pregabalin. Given with a patient control analgesia (PCA) device. Dosage of morphine used
次要结局
未报告次要终点
研究者
Kemas Muhammad Azka Novriandi
Medical doctor, Orthopaedic Surgeon, Principal Investigator
Indonesia University