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临床试验/NCT07233785
NCT07233785尚未招募不适用

Comparison of the Postoperative Analgesic Efficacy of the Combination of Adductor Canal Block and Biceps Femoris Short Head Block Versus Adductor Canal Block Alone in Patients Undergoing Total Knee Arthroplasty

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1. Numeric Rating Scale (NRS) Scores

研究概览

简要总结

The aim is to compare the postoperative analgesic effects of Adductor Canal and Biceps Femoris Short Head Blocks with Adductor Canal Block in patients undergoing Knee Arthroplasty surgery

详细描述

Patients were divided into two randomized groups: Group 1 (ACB group, n=30) and Group 2 (ACB+BiFeS group, n=30). All patients will receive the same standard spinal anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. After the surgery, patients in Group 1 will receive Adductor Canal Block (ACB) with 20 mL of 0.25% bupivacaine. Patients in Group 2 will receive Adductor Canal Block with 20 mL of 0.25% bupivacaine and Biceps Femoris Short Head (BiFeS) with 20 mL of 0.25% bupivacaine. Routine analgesic procedure consisting of 3x400mg Ibuprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 1mg/kg IV will be administered as a rescue analgesic for all patients if NRS score is higher than 4. Total Tramadol consumption will be calculated.

研究设计

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

入排标准

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

入选标准

  • •Adult patients over 18 years of age who underwent percutaneous nephrolithotomy under general anesthesia and were I-II-III according to the American Society of Anesthesiologists (ASA) risk classification were included in the study.

排除标准

  • •patients who did not give consent,
  • •patients with coagulopathy,
  • •patients with signs of infection at the block application site,
  • •patients using anticoagulants,
  • •patients with known allergies to any of the study drugs,
  • •patients with unstable hemodynamics,
  • •patients who could not cooperate during postoperative pain assessment
  • •patients who wanted to withdraw from the study,
  • •patients with alcohol and drug addiction,
  • •patients with musculoskeletal abnormalitie

研究组 & 干预措施

Adductor Canal Block

Active Comparator

For an adductor canal block, a high-frequency ultrasound probe will be placed on the anterior aspect of the patient's thigh, approximately at the midpoint between the inguinal crease and the medial condyle of the knee. (The depth is generally 3-5 cm). Using an in-plane technique, the needle will be advanced from lateral to medial, passing through the sartorius or vastus medialis muscle, and 20 mL of 0.25% bupivacaine will be injected around the femoral artery.

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

Combination of Adductor Canal Block and Biceps Femoris Short Head Block

Active Comparator

For adductor canal block, a high-frequency ultrasound probe will be placed on the anterior aspect of the patient's thigh, approximately at the midpoint between the inguinal crease and the medial condyle of the knee. (The depth is generally 3-5 cm). Using in-plane technique, the needle passing through the sartorius or vastus medialis muscle, and 20 mL of 0.25% bupivacaine will be injected around the femoral artery.

For BiFeS block, a high-frequency ultrasound probe will be placed on the distal posterior aspect of the thigh. The Biceps Femoris Short Head (BiFeS) muscle will be visualized at the distal lateral part of the femur, near the lateral supracondylar line, and the needle tip will be placed at the interface between the BiFeS and the lateral supracondylar line of the femur. 20 mL of 0.25% bupivacaine will be injected, and during the injection, it will be confirmed by ultrasound that the solution lifts the muscle and spreads along the bone surface.

干预措施: Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS) (Procedure)

结局指标

主要结局

1. Numeric Rating Scale (NRS) Scores

时间窗: Postoperative 24 hours

Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

次要结局

  • Total tramadol consumption(Postoperative 24 hours)

研究者

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

Oguz Gundogdu

Associate Professor

Cumhuriyet University

研究点 (1)

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