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临床试验/NCT07242170
NCT07242170招募中不适用

Comparison of the Effectiveness of "Sciatic Nerve", "Biceps Femoris Short Head (BiFeS)" and "Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee (IPACK)" Blocks Added to the Adductor Canal Block for Postoperative Pain Control in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Clinical Trial

Erzincan University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
Visual Analog Scale (VAS) Pain Score

研究概览

简要总结

Postoperative pain following total knee arthroplasty (TKA) is a significant clinical problem that delays early mobilization, reduces patient satisfaction, and increases analgesic requirements. The adductor canal block (ACB), which aims to provide analgesia while preserving motor function, is widely used in postoperative pain management after TKA. However, clinical and anatomical studies have demonstrated that ACB is effective only in the anteromedial sensory innervation of the knee and does not adequately block pain originating from the posterior knee capsule. This limitation reduces analgesic effectiveness, particularly in patients with a prominent posterior pain component.

The sciatic nerve block has long been considered the gold standard for managing posterior knee pain. However, due to disadvantages such as motor weakness and delayed rehabilitation, current pain management protocols increasingly favor motor-sparing and complementary approaches such as the Biceps Femoris Short Head (BiFeS) block and the Interspace Between the Popliteal Artery and the Capsule of the posterior Knee (IPACK) block for posterior knee analgesia.

In light of this information, the aim of our study is to guide clinical practice by comparing the postoperative analgesic efficacy, motor function outcomes, and patient satisfaction associated with sciatic nerve, BiFeS, and IPACK block techniques-each administered as a supplement to the adductor canal block-in patients undergoing total knee arthroplasty, with the ultimate goal of determining the optimal block combination for postoperative pain control.

详细描述

The study was designed as a prospective, single-center, double-blind, randomized controlled trial to be conducted in the operating rooms of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital. The study will begin after obtaining approval from the Erzincan Binali Yıldırım University Ethics Committee and written informed consent from all participants. A minimum of 102 patients (based on G-Power analysis), aged 18-75 years, scheduled for elective unilateral primary total knee arthroplasty by the Orthopedics and Traumatology Department and classified as American Society of Anesthesiologists (ASA) physical status I-III, will be included.

Patients with ASA ≥ IV, those undergoing revision total knee arthroplasty, bilateral arthroplasty, neuromuscular disease, cognitive dysfunction, drug allergies, a history of local anesthetic systemic toxicity, neurological deficits, bleeding diathesis, pregnancy, or those who decline participation will be excluded. The study will be conducted over a 12-month period between November 1, 2025 and November 1, 2026.

All patients will be informed about the study protocol and procedures one day before surgery, and written consent will be obtained. Upon arrival to the operating room, standard monitoring will be applied. As per routine practice, spinal anesthesia will be performed. Nasal oxygen at 2 L/min will be administered. During surgery, standard hemodynamic parameters (SpO₂, blood pressure, heart rate) will be recorded.

Spinal anesthesia will be conducted according to standard regional anesthesia protocols for total knee arthroplasty using a 25-gauge pencil-point spinal needle at the L3-L4 interspace in the sitting position. A total of 15 mg (3 mL) of 0.5% hyperbaric bupivacaine and 20 mcg (0.4 mL) fentanyl will be administered. Surgery will commence once a T10 sensory block level is achieved. Motor block will be assessed using the Modified Bromage Scale, and sensory block using pinprick or cold tests to determine dermatomal level.

At the end of surgery, under sterile conditions and ultrasound (USG) guidance, patients assigned to Group I will receive a Mid-Adductor Canal block with 20 mL (10 mL 0.25% bupivacaine + 10 mL 0.9% NaCl) and a Sciatic nerve block with 20 mL of the same local anesthetic solution. Group II patients will receive a Mid-Adductor Canal block and a BiFeS (Biceps Femoris Short Head) block using identical volumes and concentrations. Group III patients will receive a Mid-Adductor Canal block and an IPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) block with the same solution. All blocks will be performed by a single anesthesiologist with at least 3 years of experience in peripheral nerve blocks. Anesthesia technicians, operating room nurses, and postoperative assessors will be blinded to group allocation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
  • Patients undergoing primary total knee arthroplasty
  • Patients undergoing unilateral total knee arthroplasty
  • Patients between 18 and 75 years of age

排除标准

  • Patients classified as American Society of Anesthesiologists (ASA) physical status IV or higher
  • Patients undergoing revision total knee arthroplasty
  • Patients undergoing bilateral total knee arthroplasty
  • Patients with neuromuscular disease
  • Patients who decline to participate in the study
  • Patients with cognitive dysfunction
  • Patients with known drug allergies
  • Patients with a history of local anesthetic systemic toxicity
  • Patients with neurological dysfunction
  • Patients with bleeding diathesis
  • Pregnant patients

研究组 & 干预措施

Adductor Canal Block + Sciatic Nerve Block

Experimental

Procedure: Mid-Adductor Canal Block Procedure: Sciatic Nerve Block

干预措施: Adductor canal block (Procedure)

Adductor Canal Block + Sciatic Nerve Block

Experimental

Procedure: Mid-Adductor Canal Block Procedure: Sciatic Nerve Block

干预措施: Sciatic Nerve Block (Procedure)

Adductor Canal Block + BiFeS Block

Experimental

Procedure: Mid-Adductor Canal Block Procedure: BiFeS Block

干预措施: Adductor canal block (Procedure)

Adductor Canal Block + BiFeS Block

Experimental

Procedure: Mid-Adductor Canal Block Procedure: BiFeS Block

干预措施: BiFeS Block (Biceps Femoris Short Head Block) (Procedure)

Adductor Canal Block + IPACK Block

Experimental

Procedure: Mid-Adductor Canal Block Procedure: IPACK Block

干预措施: Adductor canal block (Procedure)

Adductor Canal Block + IPACK Block

Experimental

Procedure: Mid-Adductor Canal Block Procedure: IPACK Block

干预措施: IPACK block (Procedure)

结局指标

主要结局

Visual Analog Scale (VAS) Pain Score

时间窗: Postoperative 24 hours (measured at 1, 4, 8, 12, and 24 hours)

Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line with endpoints representing the extremes of pain (0 = "no pain," 10 = "worst imaginable pain"). Patients will mark their perceived pain level, and the distance (in cm or mm) from the "no pain" anchor will be recorded as the VAS score. Measurements will be performed at rest. A VAS score below 3 indicates mild pain and adequate analgesia.

次要结局

  • Postoperative Opioid Requirement(24 hours)
  • Modified Bromage Scale(24 hours)
  • QoR-40 (Quality of Recovery-40) Questionnaire(24 hours)
  • Time to First Opioid Requirement(24 hours)
  • Peroneal nerve motor function(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Somunkiran

Anesthesiology resident

Erzincan University

研究点 (1)

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