A randomized prospective comparative study of combined perineural Dexamethasone and Dexmedetomidine versus perineural Dexamethasone alone as adjuvants to Ropivacaine in adductor canal block for postoperative analgesia in patients undergoing total knee arthroplasty under subarachnoid block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Total opioid (Morphine) consumption in the first 24 hours postoperatively
研究概览
简要总结
This study is planned to evaluate the potential synergistic effect of dexamethasone and dexmedetomidine, which could have a substantial impact on postoperative analgesia for patients undergoing total knee arthroplasty. We hypothesize that combined perineural dexamethasone and dexmedetomidine as adjuvants to a local anesthetic mixture (Ropivacaine) will provide better postoperative analgesia than perineural dexamethasone alone with local anesthetics used in adductor canal block administered to patients undergoing total knee arthroplasty.
Fifty-eight patients undergoing unilateral total knee arthroplasty under subarachnoid block shall be randomly divided into 2 groups (DDR & DR) of 29 patients each. Subarachnoid block shall be administered with 3 ml 0.5% heavy Bupivacaine at L3-L4 interspace in the sitting position in either group for anesthesia. Group DDR Patients shall receive ultrasound-guided adductor canal block with 30 ml of 0.5% Ropivacaine along with Dexamethasone 4 mg & Dexmedetomidine 50 mcg after completion of surgery. Group DR patients shall receive ultrasound-guided adductor canal block with 30 ml of 0.5% Ropivacaine along with Dexamethasone 4 mg and 0.5 ml of saline after completion of the surgery. The postoperative rescue analgesia will consist of Morphine PCA (Patient Controlled Analgesia). PCA setup shall be a bolus of 1 mcg with a lockout interval of 10 mins without any background infusion (maximum dose of 6 mg/h). PCA will be started on shifting the patient to the post-anesthesia care unit (PACU) and will be continued for a period of 48 h post-op. As a part of the multimodal analgesia regime, all patients will receive Paracetamol 1 gm intravenously (8 hourly) and Diclofenac 75 mg intravenous infusion (12 hourly) in the perioperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective primary unilateral total knee arthroplasty under subarachnoid block ASA grades I-III.
排除标准
- •Patients refusing to participate in the study History of allergy to local anesthetics Patients with coagulopathy or infection at the site of block Patients with psychiatric illness or cognitive dysfunction who cannot use the patient-controlled analgesia (PCA) Patients having neuromuscular deficits, severe COPD, renal deficiency, severely compromised cardiovascular status Patients with body mass index (BMI) of > 35 kg/m2.
结局指标
主要结局
Total opioid (Morphine) consumption in the first 24 hours postoperatively
时间窗: Total opioid (Morphine) consumption in the first 24 hours postoperatively
次要结局
- Opioid (Morphine) consumption(At 48 hours postoperatively)
- NRS pain scores(At 3, 6, 12, 18, 24, 30, 36, 42 and 48 hours postoperatively, both at rest and with movement)
- Time to first requirement of rescue analgesia
- Episodes of hypotension, bradycardia and desaturation
- Functional outcome by TUG test (in seconds)(At 48 hours postoperatively)
- Ramsay sedation score
- Quadriceps muscle strength assessment by Manual Muscle Testing score (MMT)