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临床试验/NCT07248072
NCT07248072招募中不适用

Effects of iPACK and Biceps Femoris Short Head (BiFeS) Blocks Combined With Adductor Canal Block on Quality of Recovery After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Clinical Trial

Ataturk University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
2
主要终点
Quality of Recovery-15 (QoR-15) Score at 24 Hours

研究概览

简要总结

This prospective, randomized, double-blind clinical trial aims to compare the effects of two different posterior knee analgesia techniques-iPACK block (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) and the Biceps Femoris Short Head (BiFeS) block-when combined with an adductor canal block (ACB) in patients undergoing elective unilateral total knee arthroplasty (TKA). Effective postoperative analgesia is essential for early mobilization, enhanced recovery, and patient satisfaction after TKA. Although ACB provides good anterior knee analgesia while preserving quadriceps strength, additional posterior knee analgesia is often required.

The iPACK block is a commonly used technique that targets the posterior knee capsule, whereas the newer BiFeS block aims to provide more selective posterolateral sensory blockade with potentially reduced risk of motor involvement. However, comparative clinical data between these two techniques are limited.

The primary objective of this study is to evaluate the difference between the iPACK and BiFeS blocks in terms of Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively. Secondary objectives include comparisons of postoperative pain scores, opioid consumption, time to first analgesic request, quadriceps and anterior tibialis muscle strength, functional test performance, time to mobilization, active range of motion, and the incidence of adverse events.

A total of 74 adult patients scheduled for elective unilateral TKA under spinal anesthesia will be randomized in a 1:1 ratio into two groups: ACB + iPACK block or ACB + BiFeS block. All blocks will be performed under ultrasound guidance by an experienced anesthesiologist. Outcome assessments will be conducted by blinded investigators. The study aims to provide high-quality clinical evidence regarding the effectiveness of the BiFeS block compared to the widely used iPACK technique.

详细描述

This study is a prospective, randomized, double-blind, parallel-group, single-center clinical trial designed to compare the effects of two posterior knee analgesia techniques-iPACK block and Biceps Femoris Short Head (BiFeS) block-when combined with an adductor canal block (ACB) on postoperative recovery outcomes following elective total knee arthroplasty (TKA). Postoperative pain after TKA is often severe and can limit early mobilization, delay rehabilitation, and negatively affect recovery. Multimodal analgesia strategies, including regional anesthesia techniques, play an essential role in optimizing postoperative outcomes.

The adductor canal block is widely used because it provides effective anterior knee analgesia while largely preserving quadriceps motor strength. However, it does not adequately address posterior knee pain. The iPACK block is frequently used to supplement ACB, providing analgesia to the posterior knee capsule by targeting the interspace between the popliteal artery and the posterior capsule. The BiFeS block is a newer regional anesthesia technique that involves injection between the femur and the short head of the biceps femoris muscle, targeting terminal sensory branches supplying the posterolateral knee. Cadaveric and early clinical data suggest that the BiFeS block may provide more selective posterior analgesia with limited spread to motor fibers, but comparative clinical data are scarce.

The primary objective of this study is to determine whether the combination of ACB + BiFeS block results in superior quality of recovery compared to ACB + iPACK block, as measured by the QoR-15 score at 24 hours postoperatively. Secondary outcomes include QoR-15 at 48 hours; pain scores at rest and during movement; total opioid consumption at 24 and 48 hours; time to first opioid request; quadriceps and anterior tibialis muscle strength; functional performance assessed using the Timed Up and Go (TUG) and Five Times Sit-to-Stand (FTSST) tests; active knee range of motion; time to first mobilization; and the incidence of adverse events such as nausea, vomiting, pruritus, sedation, neurological symptoms, local anesthetic systemic toxicity, and postoperative falls.

Eligible participants are adults aged 18-75 years undergoing elective primary unilateral TKA under spinal anesthesia, with an ASA physical status of I-III. Exclusion criteria include allergy to study medications, coagulopathy, anticoagulant therapy, severe cardiac, hepatic, or renal dysfunction, pre-existing neuropathic pain, infection at the injection site, neuromuscular disorders of the lower limb, pregnancy, or inability to cooperate with postoperative assessments. Written informed consent will be obtained from all participants. The study has received ethics approval from the Atatürk University Clinical Research Ethics Committee.

Participants will be randomized in a 1:1 ratio using computer-generated block randomization. Both patients and outcome assessors will remain blinded to group assignments. All block procedures will be performed under ultrasound guidance by an experienced anesthesiologist not involved in postoperative assessments. Standardized perioperative management will include spinal anesthesia with hyperbaric bupivacaine, perioperative non-opioid analgesics (paracetamol, dexketoprofen), antiemetic prophylaxis, and postoperative patient-controlled analgesia with fentanyl.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and outcome assessors will remain blinded to group allocation. The anesthesiologist performing the block procedures will not participate in postoperative assessments.

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

  • Age 18-75 years
  • Scheduled for elective primary unilateral total knee arthroplasty (TKA)
  • Planned spinal anesthesia
  • ASA physical status I-III
  • Ability to understand study procedures and provide written informed consent

排除标准

  • Known allergy or hypersensitivity to local anesthetics or other study medications
  • Coagulopathy or current anticoagulant therapy
  • Severe hepatic, renal, or cardiac failure
  • History of neuropathic pain
  • Infection at the site of proposed nerve block
  • Pre-existing neuromuscular disorders in the lower extremities
  • Inability to cooperate or refusal to participate in the study
  • Pregnancy

研究组 & 干预措施

Adductor Canal Block + iPACK Block

Active Comparator

Participants in this arm will receive an ultrasound-guided adductor canal block (ACB) using 15 mL of 0.25% bupivacaine, followed by an iPACK (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) block with 25 mL of 0.25% bupivacaine. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia.

干预措施: Adductor Canal Block (ACB) Only (Procedure)

Adductor Canal Block + iPACK Block

Active Comparator

Participants in this arm will receive an ultrasound-guided adductor canal block (ACB) using 15 mL of 0.25% bupivacaine, followed by an iPACK (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) block with 25 mL of 0.25% bupivacaine. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia.

干预措施: IPACK block (Procedure)

Adductor Canal Block + BiFeS Block

Experimental

Participants in this arm will receive an ultrasound-guided adductor canal block (ACB) using 15 mL of 0.25% bupivacaine, followed by a BiFeS (Biceps Femoris Short Head) block performed by injecting 25 mL of 0.25% bupivacaine into the potential space between the femur and the short head of the biceps femoris muscle. Procedures will be performed under sterile ultrasound guidance by an anesthesiologist not involved in postoperative assessments. All participants will receive standardized spinal anesthesia and perioperative analgesia.

干预措施: Adductor Canal Block (ACB) Only (Procedure)

Adductor Canal Block + BiFeS Block

Experimental

Participants in this arm will receive an ultrasound-guided adductor canal block (ACB) using 15 mL of 0.25% bupivacaine, followed by a BiFeS (Biceps Femoris Short Head) block performed by injecting 25 mL of 0.25% bupivacaine into the potential space between the femur and the short head of the biceps femoris muscle. Procedures will be performed under sterile ultrasound guidance by an anesthesiologist not involved in postoperative assessments. All participants will receive standardized spinal anesthesia and perioperative analgesia.

干预措施: BiFeS Block (Procedure)

结局指标

主要结局

Quality of Recovery-15 (QoR-15) Score at 24 Hours

时间窗: 24 hours postoperatively

The Quality of Recovery-15 (QoR-15) questionnaire is a validated patient-reported outcome measure assessing overall postoperative recovery across domains such as pain, physical comfort, physical independence, psychological support, and emotional well-being. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome compares 24-hour QoR-15 scores between the ACB + iPACK group and the ACB + BiFeS group.

Quality of Recovery-15 (QoR-15) Score at 24 Hours

时间窗: 24 hours postoperatively

The Quality of Recovery-15 (QoR-15) questionnaire is a validated patient-reported outcome measure assessing overall postoperative recovery across domains such as pain, physical comfort, physical independence, psychological support, and emotional well-being. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome compares 24-hour QoR-15 scores between the ACB + iPACK group and the ACB + BiFeS group.

次要结局

  • Five Times Sit-to-Stand Test (FTSST)(Postoperative Day 1 and Day 2)
  • Adverse Events and Complications(Up to 48 hours postoperatively)
  • Quality of Recovery-15 (QoR-15) Score at 48 Hours(48 hours postoperatively)
  • Pain Scores (VAS) at Rest and During Movement(2, 4, 8, 12, 24, and 48 hours postoperatively)
  • Time to First Opioid Request(Up to 48 hours postoperatively)
  • Quality of Recovery-15 (QoR-15) Score at 48 Hours(48 hours postoperatively)
  • Pain Scores (VAS) at Rest and During Movement(2, 4, 8, 12, 24, and 48 hours postoperatively)
  • Timed Up and Go (TUG) Test(Postoperative Day 1 and Day 2)
  • Five Times Sit-to-Stand Test (FTSST)(Postoperative Day 1 and Day 2)
  • Time to First Mobilization(Up to 48 hours postoperatively)
  • Adverse Events and Complications(Up to 48 hours postoperatively)
  • Opioid Consumption (Fentanyl PCA)(24 and 48 hours postoperatively)
  • Active Range of Motion (Knee Flexion and Extension)(Postoperative Day 1 and Day 2)
  • Quadriceps and Anterior Tibialis Muscle Strength(4, 8, 12, 24, and 48 hours postoperatively)

研究者

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

Ahmet Murat Yayik

Principal Investigator Ahmet Murat Yayık

Ataturk University

研究点 (2)

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