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临床试验/NCT05474014
NCT05474014已完成不适用

Investigation of the Effectiveness of Superior Trunk Block Applied for Upper Arm Surgery Operation Analgesia

Bursa Yüksek İhtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. Providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery.

In this study aimed to investigate the effect of superior trunk block application on postoperative analgesic and motor functions.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class
  • Underwent upper arm surgery

排除标准

  • Previous local anesthetic allergy,
  • Having a bleeding diathesis disorder,
  • Mental disorder,
  • Allergic to the drugs used,
  • Patients who did not consent to participate in the study,
  • Presence of infection in the block area,
  • Patients with a body mass index above 30

研究组 & 干预措施

superior trunk block

Active Comparator

Ultrasound guided superior trunk block with 10 ml % 0.25 bupivacaine

  • 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: superior trunk block (Procedure)

superior trunk block

Active Comparator

Ultrasound guided superior trunk block with 10 ml % 0.25 bupivacaine

  • 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: intravenous patient-controlled analgesia (Drug)

tramadol

Active Comparator

400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: intravenous patient-controlled analgesia (Drug)

结局指标

主要结局

Visual Analog Scale

时间窗: Postoperative 24 hours

Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)

次要结局

  • additional analgesic use amount(Postoperative 24 hours)
  • postoperative complications(Postoperative 24 hours)
  • Horner syndrome(Postoperative 24 hours)
  • tramadol consumption amount(Postoperative 24 hours)

研究者

发起方
Bursa Yüksek İhtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Korgün Ökmen

Assoc.Phd.M.D

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (1)

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