Comperative Evaluation of Intraosseous Regional Analgesia using Diclofenac, Morphine, Lignocaiine and placebo in Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.
研究概览
简要总结
This Phase 2 randomized controlled trial evaluates the efficacy and safety of intraosseous regional analgesia using morphine, lignocaine, and diclofenac in patients undergoing bilateral total knee arthroplasty. Postoperative pain intensity (VAS) and total opioid consumption will be assessed up to 48 hours. The study aims to determine whether this technique provides effective pain control with minimal adverse effects, potentially improving postoperative recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 50–75 years undergoing simultaneous bilateral total knee arthroplasty under spinal anesthesia and epidural analgesia Diagnosed with bilateral end-stage osteoarthritis of the knee ASA (American Society of Anesthesiologists) physical status Class I–III Willing and able to provide informed written consent.
排除标准
- •Known allergy or hypersensitivity to lignocaine, morphine, diclofenac, or other NSAIDs Patients with coagulopathy or on anticoagulants that cannot be discontinued History of chronic opioid use, substance abuse, or opioid tolerance Renal or hepatic impairment Active local or systemic infection History of neurological disorders or psychiatric illness affecting pain perception or communication Revision TKA or prior major surgery on either knee If surgery went prolonged more then 4 hrs If during surgery any intraop complication happens.
- •if patient having rhematoid arthritis.
结局指标
主要结局
To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.
时间窗: To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.
次要结局
- To evaluate & compare the postoperative pain relief provided by intraosseous administration of Diclofenac, Morphine, Lignocaine & Control using standardized pain scores (e.g., Visual Analog Scale) at 6, 12, 24 & 48hrs predefined time intervals.(To evaluate the time to first rescue analgesia postoperatively among the four groups.)
研究者
Dr Khushwant Meena
PGIMER chandigarh