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临床试验/NCT05960422
NCT05960422已完成不适用

Effects of Adding Adductor Canal Block to Popliteal Sciatic Nerve Block in Hallux Valgus Correction Operations

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年9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
已完成
发起方
入组人数
52
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

The goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. The main question it aims to answer are:

  • Does peroperative pain decrease?
  • Do patient-surgeon satisfaction increase? The patients were divided into two groups, the Popliteal Sciatic Block (PSB) group, and the Popliteal Sciatic Block + Adductor Canal Block (PSB + ACB) group.

详细描述

Patients were randomly assigned into 2 groups as popliteal sciatic nerve block (Group PSB), popliteal sciatic nerve + adductor canal block (Group PSB + ACB). In this study, 52 patients scheduled for hallux valgus correction operations, in the American Society of Anesthesiologists I-III groups, between the ages of 18-80, were enrolled. Study was planned as a prospective, randomized and controlled trial. All patients were perfomed PSB with 10 ml 0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to the patients in the ACB + PSB group in the supine position, in addition to PSB. Patients with coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities, peripheral artery disease, mental retardation and those who did not give consent to study were excluded. All patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. After the blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet pain, motor block time, pain onset time, first analgesic administration time (NPRS≥4) and analgesic administered were recorded. Anesthesiologists evaluating these data were blinded to group distribution .

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged between 18 and 80
  • •American Society of Anesthesiologists ASA I-III

排除标准

  • •Patients with coagulopathy
  • •Patient with wounds or infections in the region
  • •Patient with allergies to local anesthetic drugs
  • •Patient with significantly impaired peripheral neuropathy and neurogenic disorders affecting the lower extremity
  • •Patient with peripheral arterial disease
  • •Patient with mental retardation

研究组 & 干预措施

Popliteal Sciatic Nerve Block

Active Comparator

Patients are in the group undergoing popliteal sciatic block

干预措施: Popliteal Sciatic Nerve Block (Procedure)

Adductor Canal Block

Active Comparator

Patients are in the group undergoing popliteal sciatic block + adductor canal block

干预措施: Adductor canal block (Procedure)

结局指标

主要结局

Postoperative Pain

时间窗: Postoperative 24 hours

The Numeric Pain Rating Scale (NPRS). Between 1-10. The low values mean low pain and a better outcome.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi POLAT

Principal Investigator

Istanbul Medeniyet University

研究点 (1)

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