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临床试验/CTRI/2024/03/063773
CTRI/2024/03/063773
已完成
2 期

To Evaluate the analgesic efficacy of the anterior femoral cutaneous nerve block (AFCNB) combined with the adductor canal block (ACB) in patients undergoing unilateral total knee replacement (TKR) : A randomized controlled trial

Josemine Davis1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月15日最近更新:

概览

阶段
2 期
状态
已完成
发起方
Josemine Davis
入组人数
80
试验地点
1
主要终点
To Evaluate Postoperative Pain Relief

概览

简要总结

Pain management is a fundamental aspect of patient care after orthopaedic surgery. As surgical techniques continue to advance, so do the methods of perioperative pain control. Among the many strategies for postoperative analgesia, peripheral nerve blocks have gained recognition as effective tools in reducing pain and opioid consumption, and promoting early ambulation after Total Knee Replacement (TKR) surgeries. Adductor canal block (ACB) has shown promise in providing effective pain relief and is motor sparing as it targets the sensory division of the femoral nerve (Saphenous nerve). However, some recent studies have shown that it covers only limited area of the incision site and provide only partial analgesia[1]. Blocking, the Intermediate and Medial cutaneous nerve together known as the Anterior femoral cutaneous nerve, that covers the supply of anterior and medial aspect of thigh and knee has shown to provide excellent analgesia in one of the studies. However, further studies are needed to overcome the limitations and provide additional evidence of the benefit of combining Anterior femoral cutaneous nerve block (AFCNB) with Adductor canal block (ACB).

This study aims to evaluate the analgesic efficacy of the AFCNB combined with the ACB versus adductor canal block (ACB) alone in patients undergoing TKR surgeries. It will shed light on the optimal technique for improved postoperative pain management and patient satisfaction. This study also endeavours to address a significant gap in current knowledge and inform clinical practice, ultimately enhancing the quality of care for patients after total knee replacement.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18 years and older undergoing unilateral TKR
  • ASA classification I-III.
  • Patients capable of providing informed consent or with consent provided by a legal guardian.
  • Patients who can comprehend and cooperate with study procedures and pain assessment tools.

排除标准

  • Patients with contraindications or allergies to local anaesthetics used in nerve block procedures.
  • Patients scheduled for emergency orthopaedic procedures.
  • Patients with chronic opioid use or opioid tolerance.
  • Patients with pre-existing neurological disorders that may affect pain perception.
  • Known allergies to components of the nerve block procedures.
  • Patients with active infections or open wounds at the site of the nerve block.
  • Pregnant or lactating women.
  • Patients currently enrolled in other clinical trials or studies involving pain management techniques.

结局指标

主要结局

To Evaluate Postoperative Pain Relief

时间窗: At baseline , 24 hours postoperatively

次要结局

  • To examine functional outcomes: Assess the impact of the AFCNB & ACB on early ambulation & functional recovery in the immediate postoperative period. The Timed Up & Go (TUG) test results at 24 hours postoperatively will be noted in comparison to pre-op TUG test results.(24 hours)

研究者

发起方
Josemine Davis
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vipin Dalal

Army Hospital Research and Referral

研究点 (1)

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