A COMPARATIVE EVALUATION BETWEEN A COMBINATION OF PERICAPSULAR NERVE GROUP (PENG) BLOCK AND LATERAL FEMORAL CUTANEOUS NERVE (LFCN) BLOCK AS AN ADJUNCT TO SPINAL ANAESTHESIA VERSUS COMBINED SPINAL EPIDURAL ANAESTHESIA FOR POSTOPERATIVE ANALGESIA AND FUNCTIONAL RECOVERY FOLLOWING TOTAL HIP ARTHROPLASTY: A RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Pain Scores
研究概览
简要总结
Eligible patients will be randomly allocated into two groups to receive either Pericapsular Nerve Group (PENG) block with Lateral Femoral Cutaneous Nerve (LFCN) block as an adjunct to Spinal Anaesthesia (Group - A) or Combined Spinal Epidural Anaesthesia (Group B). Randomization will be achieved using computer-generated lists and treatment allocation concealed using consecutively numbered, sealed, opaque envelopes. Every patient will be informed of the sequence of procedures during anaesthesia and surgery, and signed informed consent in their vernacular language will be obtained before enrolment.
Group A will receive Spinal Anaesthesia under all aseptic precautions using Quincke spinal needle 25G/26G in L2-L3 / L3-L4 space. Inj Bupivacaine H 0.5% 2.5ml with Inj Fentanyl 25mcg 0.5ml will be administered in the subarchnoid space. After receiving spinal anaesthesia patients will be givenultrasound guided Pericapsular Nerve Group (PENG) block and Lateral Femoral Cutaneous nerve block preoperatively using stimuplex needleand Inj Bupivacaine 0.25% plain 20ml will be given for PENG block and 5ml for Lateral Cuteness Femoral Nerve Block.
Group B will receive Combined Spinal Epidural Anaesthesia under all aseptic conditions. Spinal Anaesthesia using Quincke spinal needle 25G/26G in L2-L3 / L3-L4 space and Inj Bupivacaine H 0.5% 2.5ml with Inj Fentanyl 25mcg 0.5ml will be given. Epidural Anaesthesia will be given using 18G Touhy’s needle and catheter will be left in situ. Postoperative controlled drug administration of InjBupivacaine 0.125% through epidural catheter will be done and infusion will be started at 5ml/hr initially which will be titrated in the next 1-2 days according to the pain. In both the groups, rescue analgesia of Inj Tramadol 100mg iv will be administered as requirement basis.
At all postoperative time points (0, 6, 12, 24 hr) patients will be asked to indicate perceived pain using a 0-10 VAS score (0- No pain, 10- Worst pain). Motor recovery of the hip joint will be assessed at 24 h using range of motion, where active hip flexion (between 0° and 90°) will be measured using a goniometer. In addition, ‘time to first walk’, defined as the time between the end of surgery and the ability to take at least three steps with the help of the walker, will be recorded after the first 12 postoperative hours, and re-evaluated on the first postoperative day. Outcome assessment will be performed by a different clinician who will be blinded to the group allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Physical status I- III
- •Patient consent to participate in the study.
排除标准
- •Refusal to participate in the study.
- •Patients having coagulopathy.
- •Patients allergic to local anesthetic (LA)
- •Patients having sepsis.
- •Patients with hepatic or renal failure,
- •Pregnant patients.
结局指标
主要结局
Postoperative Pain Scores
时间窗: 0,6,12,24 hours
Postoperative Motor strength
时间窗: 0,6,12,24 hours
次要结局
- Use of Rescue Analgesia(Time to 1st walk)
研究者
Sudarshan Kumar Garg
Army Hospital Research and Referrall, New Delhi
