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临床试验/NCT06973447
NCT06973447已完成不适用

Comparison of the Effects of Combined Anterior Suprascapular Nerve Block and Infraclavicular Brachial Plexus Block Versus Costoclavicular Brachial Plexus Block on Postoperative Pain and Hemidiaphragmatic Paralysis in Shoulder Arthroscopy

Cumhuriyet University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Numeric Rating Scale (NRS) Scores

研究概览

简要总结

The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Anterior SupraScapular Nerve Block (ASSNB) and InfraClavicular Brachial Plexus Block (ICBPB) combination versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing shoulder arthroscopic surgery.

详细描述

Patients were divided into two randomized groups: Group 1 (ASSNB+ICBPB Combination group, n=15) and Group 2 (CCBPB group, n=15). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. Before the anesthesia induction, ipsilateral diaphragmatic excursion will be measured via Ultrasonography (USG). After the anesthesia induction, patients in Group 1 will receive anterior suprascapular nerve block (ASSNB) with 10 mL of 0.25% bupivacaine and infraclavicular brachial plexus block (ICBPB) with 15 mL of 0.25% bupivacaine (with a total volume of 25 mL). Patients in Group 2 will receive costoclavicular brachial plexus block (CCBPB) with 15 mL of 0.25% bupivacaine. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring), ipsilateral diaphragmatic excursion will be assessed again. Pre- and postblock excursion differences will be recorded. Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen 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. Quality of Recovery-15 Patient Survey will be done both preoperatively for a baseline score, and postoperatively at 24th hour to assess the quality of recovery from the patients' view. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or 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
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients older than 18 years of age who underwent arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

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 local anesthetic drug allergies,
  • patients with unstable hemodynamics,
  • patients who could not cooperate during postoperative pain assessment

结局指标

主要结局

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.

Diaphragmatic Excursion Difference

时间窗: Preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring)

Ipsilateral diaphragmatic excursions will be measured both preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring). A diaphragmatic excursion change of up to 25% indicates no nerve involvement, a change between 25%-75% indicates partial involvement, and a change exceeding 75% indicates complete involvement of the phrenic nerve.

次要结局

  • Quality of Recovery-15 Patient Survey (QoR-15)(Preoperatively and Postoperatively at 24th hour)
  • 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 (2)

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