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临床试验/CTRI/2024/07/070621
CTRI/2024/07/070621尚未招募2/3 期

Comparison of 4 in 1 block with modified 4 in 1 block using ultrasound for postoperative analgesia in cruciate ligament reconstruction in knee surgeries.

Department of Anaesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare 4 in 1 block with modified 4 in 1 block using ultrasound for post-operative analgesia in cruciate ligament reconstruction in knee surgeries by comparing the difference of VAS (visual analogue scale) scores between the two groups for 48 hours after surgery.

研究概览

简要总结

Total knee arthroplasty or replacement (TKA), arthroscopic knee surgeries are one of the most commonly performed, life-changing surgical procedures, leading to improved health-related quality of life and functional status, therefore these surgeries demand better outcomes with minimal morbidity and mortality and early mobilisation and discharge. The central neuraxial blocks were associated with higher complications, morbidity and delayed ambulation. The regional techniques provide a better and early outcome as compared to the central neuraxial techniques. Regional analgesia (RA) is an important component of multimodal analgesia to deal with perioperative pain. Regional anaesthesia includes epidural analgesia, femoral nerve block, adductor canal block, sciatic nerve block, IPACK, etc. But these blocks have many drawbacks. Femoral nerve block is associated with quadriceps muscle weakness leading to delay in patient’s mobility. Sciatic nerve block also causes foot drop. The Adductor canal block does not cover the skin on the back of the knee. Surgeons refuse IPACK because of diffusion of local anaesthetics disturbs the anatomy of the surgical field. 70 Patients between the age group of 20 to 50 years old of either sex belonging to ASA I and II will included in the study. Using computer generated randomisation, patients will be allotted in to two groups of 35 each. One group will receive the newly developed regional technique Modified 4 in 1 block with the addition of USG and PNS guided Vastus medialis nerve block. The patients in this block will receive 20ml injection bupivacaine 0.25% and 2ml of injection dexamethasone 8mg added as adjuvant (total volume of drug 22ml). The second group will receive the 4 in 1 block. In this technique , the vastus and sartorius intersection (antero medial intermuscular septum) will be identified and the probe will be slide proximally till the superficial femoral artery appearing in the adductor hiatus. The probe will slide slowly proximally till the descending genicular artery branching from superficial femoral artery will be visualized in the hiatus. This point will be the point of interest. The point will be 8–10 cm above the femoral condyle. At this point, 20 mL of 0.25% Bupivacaine and 2ml (8mg) dexamethasone will be injected after confirmation of negative aspiration of blood and no excess pressure upon injection. The needle was guided further in plane from lateral to medial side under USG guidance to reach perivascular region and after negative aspiration 22ml of total drug will be injected, visualized to push the femoral artery posteriorly ( total amount of drug given is 22ml). The patient’s vitals, VAS score, total analgesic consumption and quadriceps muscle strength will be noted at regular intervals for 48 hours post operatively and the data will be compiled and will be send for statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ASA I and II ,who are to undergo elective orthopaedic cruciate ligament reconstruction in knee surgery, under subarachnoid block.

排除标准

  • Known hypersensitivity or allergy to study drugs.
  • Bleeding disorders.
  • Infection at the site of the block.
  • Uncontrolled diabetes mellitus and hypertension.
  • History of cardiac, liver or kidney disease.

结局指标

主要结局

To compare 4 in 1 block with modified 4 in 1 block using ultrasound for post-operative analgesia in cruciate ligament reconstruction in knee surgeries by comparing the difference of VAS (visual analogue scale) scores between the two groups for 48 hours after surgery.

时间窗: To compare 4 in 1 block with modified 4 in 1 block using ultrasound for post-operative analgesia in cruciate ligament reconstruction in knee surgeries by comparing the difference of VAS (visual analogue scale) scores between the two groups for 48 hours after surgery.

次要结局

  • To note duration of postoperative analgesia using VAS in both groups up to 48hours after surgery.(To note the site of pain, whether it is medial, lateral or upper side of knee)

研究者

发起方
Department of Anaesthesiology and Critical Care
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anju Ghai

Pt. BD Sharma PGIMS Rohtak

研究点 (1)

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