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临床试验/CTRI/2025/02/080817
CTRI/2025/02/080817尚未招募3 期

A comparative study on the efficacy of PENG block with either supra-inguinal fascia iliaca block or circum-psoas block for postoperative analgesia in elderly patients undergoing surgery for proximal hip fractures

Sancheti Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
24-hrs opioid consumption

研究概览

简要总结

The fascia iliaca block is a commonly used compartment block for cutaneous analgesia for hip surgery. The hip joint is innervated by branches of the femoral nerve (FN), obturator nerve (ON), and sciatic nerve (SN). The lateral femoral cutaneous nerve (LFCN) should also be blocked if the surgical incision extends to the lateral side of the thigh. The FN, ON, and LFCN are all part of the lumbar plexus, implying that blocking the lumbar plexus is an elegant way to provide postoperative analgesia for THA. The fascia iliaca compartment block (FICB) can be regarded as an anterior approach of the lumbar plexus. This block anesthetizes the lateral femoral cutaneous nerve but has reported failure rates of 10% to 37%. Moreover, a recent study failed to demonstrate the benefit of a “classic” transverse FICB at the level of the FN for postoperative analgesia after hip arthroplasty. Supra-inguinal fascia iliaca (SIFI) block is a novel regional anaesthesia technique that was first described by Hebbard et al. in 2015 as an alternative technique to the classic infrainguinal fascia iliaca block on the presumption that it will provide a wider local anaesthetic spread and better coverage of the lateral femoral cutaneous nerve. The course of the lateral femoral cutaneous nerve below the inguinal ligament is variable as opposed to consistent above the inguinal ligament in the pelvis. The authors used a supra-inguinal ultrasound-guided technique and placed local anaesthetic directly into the iliac fossa and found that it leads to extensive fluid spread throughout the iliac fossa. They described consistent staining of the femoral nerve and lateral femoral cutaneous nerve in their cadaveric dye study. Subsequently, many clinical studies demonstrated its analgesic efficacy. One study comparing lumbar plexus block versus SIFI block for total hip arthroplasty found that SIFI block provided equivalent analgesic efficacy and longer duration of analgesia.

Circumpsoas block (CPB) is a recently described block which is an anterior myofascial plane block for lumbar plexus elements. In an attempt to improvise the analgesia in patients with femoral fractures,  local anesthetic was deposited deep to anterior psoas fascia under ultrasound guidance to block lumbar plexus elements which emerge lateral, anterior, and medial to the psoas major muscle. . Clinical and computed tomography contrast studies revealed that a continuous CPB infusion with a catheter provided a reliable block of the lumbar plexus elements. No adverse were events noted. Hence, it is implied that US guided CPB is a reliable technique for managing postoperative pain after surgery of femur fractures. Since SIFI block does not provide coverage for obturator nerve, we hypothesized that PSB would provide a superior pain relief compared to SIFI block. At present, no study has compared these two regional anesthesia techniques. Hence, we decided to compare the two techniques for postoperative analgesic efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • proximal femur fracture surgery (intertrochanteric, neck of femur and subtrochanteric fractures) and consenting for the trial.

排除标准

  • inability or refusal to sign informed consent, younger than 18 years, BMI greater than 35 kg/m2, intolerance to any of the drugs used in the study, a history of hepatic or renal insufficiency, coagulopathy, using chronic analgesic drugs; having additional illnesses, including liver or kidney diseases, neurological deficits in the lower extremities and illnesses that interfered with communication skills such as dementia or mechanical ventilation requirement.

结局指标

主要结局

24-hrs opioid consumption

时间窗: 24-hrs

次要结局

  • 1. Time to the first analgesia(2. Resting NRS scores at 0, 2, 8, 12, 24 hrs)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sandeep Madhusudan Diwan

Sancheti Hospital, Pune

研究点 (1)

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