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临床试验/NCT06827912
NCT06827912已完成不适用

Comparison of Postoperative Analgesic Effects of Interscalene and Shoulder Anterior Capsule Block in Arthroscopic Rotator Cuff Operations

Amasya University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年2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
已完成
入组人数
46
试验地点
1
主要终点
Postoperative 12th hour pain score

研究概览

简要总结

Due to the development and easy availability of ultrasonography devices, regional nerve blocks are routinely used by anesthesiologists among multimodal analgesia techniques. Interscalene and supraclavicular nerve blocks are the leading regional anesthesia techniques for shoulder surgeries. However, due to the phrenic nerve involvement and loss of motor function in the upper extremity in these block techniques, new nerve blocks have been developed and used for postoperative analgesia. One of the blocks that has been used increasingly in shoulder region surgeries and does not cause phrenic nerve involvement is the shoulder anterior capsule block (SHAC). The aim of this study is to compare the postoperative analgesic effects of interscalene nerve block and SHAC block in patients undergoing arthroscopic rotator cuff repair surgery.

详细描述

Shoulder arthroscopy is one of the most frequently performed orthopedic procedures today. Although it is a minimally invasive procedure, it has been associated with severe postoperative shoulder pain and many techniques have been investigated for pain management. Today, anesthesiologists try to control postoperative pain well as one of the important components of enhanced recovery after surgery (ERAS), as this increases patient comfort and accelerates recovery. At the same time, opioids are tried to be avoided as much as possible while controlling pain due to their serious side effects. For these reasons, interscalene nerve block is frequently used in shoulder arthroscopy patients and provides highly effective and long-lasting postoperative analgesia. Interscalene block can also be used alone for surgical anesthesia in patients undergoing shoulder arthroscopic surgery and is accepted as the gold standard regional anesthesia technique. However, due to phrenic nerve involvement in interscalene block and loss of motor function in the upper extremity, new nerve blocks continue to be discovered for postoperative analgesia.

In 2020, Altinpulluk et al. showed that methylene blue applied to the deep subscapular muscle in a cadaver, between the humerus head and the area, stained the entire shoulder joint capsule and a certain amount of the axillary region, and they named this new block as pericapsular nerve block (PENG). Kupeli et al. and Ramudarai et al. applied the local anesthetic drug to the interfascial area between the deltoid muscle and the subscapular muscle and named this block as PENG block. The investigators think that this is the axillary nerve block with the Fajardo approach defined by Altınpulluk et al. Because in the cadaver study conducted by Gonzalez et al., it was shown that methylene blue applied between the deltoid muscle and the subscapular muscle did not spread to the pericapsular area. Nevertheless, postoperative analgesia was provided with the local anesthetic drug applied with both approaches and a motor protective effect was demonstrated. The injection made in both areas together can be called shoulder anterior capsule block (SHAC).

In our clinic, in our routine practice, the investigators perform the anesthesia procedure of patients who will undergo arthroscopic rotator cuff repair without general anesthesia, only with interscalene block. Since the SHAC block, which is a relatively new block mentioned above, does not provide sufficient surgical anesthesia on its own, patients must also be placed under general anesthesia. Our study aims to compare patients who have arthroscopic rotator cuff repair under general anesthesia with SHAC block and patients who have arthroscopic rotator cuff repair with interscalene block alone in terms of postoperative analgesia and motor-protective effects.

Materials and methods Ethics This double-blind, single-center, parallel-arm, randomized controlled study was approved by Hitit University Research Ethics Committee, numbered 2024-106. The study will be conducted at Amasya University Sabuncuoğlu Şerefeddin Education and Research Hospital.

Randomization and blinding Patients will be randomly assigned to two equal groups (ISC group or SHAC group) using a computer-assisted randomization method using the "Research Randomizer" program (www.randomizer.org), 46 patients in a 1:1 ratio. Due to the nature of the interventions, blinding will not be possible for the anesthesiologist administering the anesthesia. However, in order to minimize bias, the investigators responsible for the evaluation of postoperative recovery times, pain scores, and opioid-related side effects will be blinded to group assignment throughout the study.

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)

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
否

入选标准

  • •ASA 1-2 patients who will undergo arthroscopic rotator cuff repair,
  • •Patients between the ages of 18-75

排除标准

  • •Allergy to local anesthetics
  • •Infection at the block site
  • •Neuropathy in the involved extremity
  • •History of chronic opioid use
  • •Revision surgery
  • •History of hepatic and renal failure
  • •History of peripheral neuropathy
  • •History of diabetes mellitus

研究组 & 干预措施

Interscalene Block Group

Active Comparator

干预措施: Shoulder Anterior Capsule Block (Procedure)

SHAC Block Group

Active Comparator

干预措施: Interscalene Nerve Block (Procedure)

结局指标

主要结局

Postoperative 12th hour pain score

时间窗: Postoperative 12th hour

Postoperative 12th hour pain score (will be evaluated with Numeric Rating Scale) Higher scores indicate worse condition

次要结局

  • Postoperative 1, 2, 4, 8, 12, 16, 24, 48 hours pain score(Postoperative 1, 2, 4, 8, 12, 16, 24, 48 hours)
  • Amount of opioid consumption(in the first 24 hours postoperatively)
  • Complications related to opioid use(in the first 24 hours postoperatively)
  • Elephant flexion motor strength evaluation(in the first 24 hours postoperatively)
  • Surgeon satisfaction level with Likert scale(during surgery)
  • Patient satisfaction level with Likert scale(postoperative 24th hour)

研究者

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

Bülent Meriç Çam

Specialist Doctor

Amasya University

研究点 (1)

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