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临床试验/NCT07278050
NCT07278050招募中不适用

Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management After Arthroscopic Shoulder Surgery: A Randomized Prospective Study

Medipol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Opioid consumption (fentanyl)

研究概览

简要总结

Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.

Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after shoulder surgery.

The aim of this study is to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.

详细描述

Postoperative pain is an important issue in patients who have undergone arthroscopic shoulder surgery. Pain causes a few problems: uncomfortable patients, negative outcomes, and longer rehabilitation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization, such as infection and thromboembolism, may be reduced. Various techniques may be used for postoperative pain treatment. Opioids are one of the most preferred drugs among analgesic agents. Parenteral opioids are generally administered to patients after surgery. However, opioids have undesirable adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events).

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are commonly used. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.

US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided.

In the cadaveric study of Tulgar et al., it was determined that the spread of the serratus posterior superior interfacial plane block, 7-10 intercostal levels on the left side, only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region, such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of the SPSP block for postoperative analgesia management after shoulder surgery.

This study aims to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery. The primary aim is to compare postoperative opioid consumption (fentanyl), and the secondary aim is to evaluate postoperative pain scores (NRS), adverse effects related to opioids (allergic reaction, nausea, vomiting).

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)

盲法说明

The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.

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

入选标准

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for arthroscopic shoulder surgery under general anesthesia

排除标准

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedure

研究组 & 干预措施

Group SPSIPB = SPSIPB group

Active Comparator

SPSIPB will be performed

干预措施: Serratus posterior superior intercostal plane block (Drug)

Group SPSIPB = SPSIPB group

Active Comparator

SPSIPB will be performed

干预措施: Postoperative analgesia management (Drug)

Group ESPB = ESPB group

Active Comparator

ESPB will be performed

干预措施: Erector spinae plane block (Drug)

Group ESPB = ESPB group

Active Comparator

ESPB will be performed

干预措施: Postoperative analgesia management (Drug)

结局指标

主要结局

Opioid consumption (fentanyl)

时间窗: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours

The primary aim is to compare postoperative opioid consumption

次要结局

  • Pain scores (Numerical rating scores-NRS)(Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours)
  • Need for rescue analgesia (meperidine)(Postoperative 24 hours period)
  • Adverse events(Postoperative 24 hours period)

研究者

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

Bahadir Ciftci

Principal Investigator

Medipol University

研究点 (1)

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