A Tale of Two Blocks: Comparing Adductor Canal and Dual Subsartorial techniques in Total Knee Replacement.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PRIMARY OBJECTIVE:
研究概览
简要总结
A Tale of Two Blocks: Comparing Adductor Canal and Dual Subsartorial Techniques in Total Knee Replacement will be a prospective randomized controlled trial to evaluate postoperative analgesia and motor performance in patients undergoing total knee replacement (TKR), which often causes significant pain impeding mobility and recovery. Peripheral nerve blocks like Adductor Canal Block (ACB) and Dual Subsartorial Block (DSB) provide targeted relief while preserving motor function, and this study will compare their efficacy. The primary aim will be to assess differences in analgesia and motor function, with objectives measuring analgesia duration, total rescue analgesic dose in the first 24 hours, VAS scores at 2, 4, 6, 12, and 24 hours postoperatively, and motor performance with knee range of motion. Secondary objectives will analyze complications from ACB, DSB, and post-anesthesia care, plus drug side effects.
The study will be conducted at MMI Narayana Multi-Speciality Hospital in Raipur, Chhattisgarh, over 24 months post-IEC and CTRI approval, including ASA I-II patients aged 18-75 scheduled for TKR, excluding those under 18 or over 75, ASA III-IV, with infections, pregnancy, lactation, psychological/neurological/coagulation issues, or drug allergies. Preoperative tests will include CBC, PT/INR, blood sugar, electrolytes, ECG, chest X-ray, and liver/kidney function. After informed consent, patients will be randomized into ACB or DSB groups, premedicated with pantoprazole 40 mg and alprazolam 0.25 mg nightly, receiving subarachnoid block with 3.4 ml 0.5% hyperbaric bupivacaine. Postoperative ultrasound-guided blocks will use 35 ml 0.25% bupivacaine (17.5 ml 0.5% bupivacaine + 17.5 ml sterile water), monitoring vitals, VAS, motor function, and complications for 24 hours with rescue analgesia as needed.
Sample size will be 60 (30/group), calculated at 99% CI and power from prior data (DSB analgesia: 6.155±0.898 vs. 4.833±0.791), adding 10 for attrition. Data in MS Excel will be analyzed via SPSS 21.0 using t-tests/Mann-Whitney U for continuous variables, Chi-square/Fisher exact for categorical, with p<0.05 significant.
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
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age 18-75 years of ASA I and II Physical Classes, posted for Total Knee Replacement.
排除标准
- •Age less than 18 and more than 75, ASA III and IV, Infection at injection site, Pregnancy, lactating mother, Patient with psychological, neurological or coagulation disorder, History of allergy to local anaesthetics or drugs used in the study.
结局指标
主要结局
PRIMARY OBJECTIVE:
时间窗: *RESCUE ANALGESIA IN FIRST 24HOURS | * VAS (Visual Analog Scale) score for pain at 2, 4, 6, 12 and 24 hours post-operatively. | *Motor performance and Range of movement in the knee joit--WITHIN 24 HOURS.
1) Duration of post-operative analgesia.
时间窗: *RESCUE ANALGESIA IN FIRST 24HOURS | * VAS (Visual Analog Scale) score for pain at 2, 4, 6, 12 and 24 hours post-operatively. | *Motor performance and Range of movement in the knee joit--WITHIN 24 HOURS.
2) Total dose of rescue analgesic required in first 24 hours.
时间窗: *RESCUE ANALGESIA IN FIRST 24HOURS | * VAS (Visual Analog Scale) score for pain at 2, 4, 6, 12 and 24 hours post-operatively. | *Motor performance and Range of movement in the knee joit--WITHIN 24 HOURS.
3) VAS (Visual Analog Scale) score at 2, 4, 6, 12 and 24 hours post-operatively.
时间窗: *RESCUE ANALGESIA IN FIRST 24HOURS | * VAS (Visual Analog Scale) score for pain at 2, 4, 6, 12 and 24 hours post-operatively. | *Motor performance and Range of movement in the knee joit--WITHIN 24 HOURS.
4) Motor performance and Range of movement in the knee joint in post operative period.
时间窗: *RESCUE ANALGESIA IN FIRST 24HOURS | * VAS (Visual Analog Scale) score for pain at 2, 4, 6, 12 and 24 hours post-operatively. | *Motor performance and Range of movement in the knee joit--WITHIN 24 HOURS.
次要结局
- SECONDARY OBJECTIVE:(1) To analyse the incidences of complications, if any, associated with Adductor Canal Block, Dual Subsartorial Block & Pre Anesthesia Checkup)
研究者
MANISH CHOUBEY
MMI NARAYANA SUPERSPECIALITY HOSPITAL,RAIPUR
