跳至主要内容
临床试验/CTRI/2024/08/072985
CTRI/2024/08/072985尚未招募Phase 3 4

To study the analgesic effectiveness of anterior femoral cutaneous nerve block in addition to proximal adductor canal block and local infiltration analgesia in patients undergoing unilateral primary total knee arthroplasty: A randomised controlled trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月4日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Cumulative postoperative analgesic consumption in 36 hours as IV morphine equivalents

研究概览

简要总结

Total knee arthroplasty (TKA) is commonly conducted surgery and about 2.5 lakh people undergo TKR in India every year. Failure to provide adequate analgesia may affect physical rehabilitation, which is important to improve joint range of motion and promote satisfactory results.Various different peripheral nerve blockade techniques such as sciatic nerve block, obturator nerve block which anaesthetize the posterior part of knee, femoral nerve block and adductor canal block taking care of the anteromedial aspect of knee and obturator nerve block have been described.Femoral nerve block caused motor blockade of the quadriceps femoris muscle so to overcome this motor sparing adductor canal block was given.In order to cover the posterior aspect of knee, infiltration between the popliteal artery and capsule of the knee (IPACK) was introduced and combination of ACB with IPACK was preferredThe advent of local infiltration anaesthesia which is given around the knee involving the medial and lateral remnants, posterior capsule found noninferior to IPACK.So, the standard block preferred for TKR is ACB+LIA. Though ACB+LIA is better it cannot cover the anterior or anteromedial skin incision of the TKR surgery as the dermatomal distribution of this area is supplied by Anterior cutaneous femoral nerve. So, we hypothesize that, additional Anterior femoral cutaneous block, along with proximal ACB and LIA, will empower analgesia and will reduce the opioid consumption and improves postoperative recovery.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA I+II+III 2) 18 TO 70 Years 3) Patients undergoing unilateral primary Total knee arthroplasty.

排除标准

  • 1.Patient refusal 2.Varus valgus deformity > 20 degree 3.Flexion deformity > 30 degree 4.BMI > 30 kg/sq.cm 5.Contraindication to neuraxial anaesthesia 6.Allergy to local anaesthetics, NSAIDS, Opioids 7.Chronic opioid use > 3 month duration 8.Previous knee surgery 9.Pregnant females at the time of recruitment 10.Progressive neurological deficit in femoral, obturator or sciatic nerve distribution.
  • 11.Severe cardiac co-morbidities, hepatic or renal dysfunction, coagulopathy.

结局指标

主要结局

Cumulative postoperative analgesic consumption in 36 hours as IV morphine equivalents

时间窗: 36 hours

次要结局

  • 1.Numeric rating scale of pain (0 minimum-10 worst pain) at various intervals(2.NRS at movement after mobilization at various time intervals)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Debesh Bhoi

AIIMS New Delhi

研究点 (1)

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