Ultrasound-Guided Erector Spinae Plane Block or Interscalen Brachial Plexus Block Following Arthroscopic Shoulder Surgery

Not Applicable

Completed

• Conditions: Shoulder Syndrome
• Interventions: Other: Erector spinae plane block (Group E); Other: Interscalen brachial plexus block (Group I)

• Registration Number: NCT04083287
• Lead Sponsor: Medipol University

Brief Summary

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

The US-guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. Local anesthetic injection is administrated into the deep fascia of erector spinae. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level, and lumbar analgesia at T10-12, L3 levels. There are a few case reports about the efficacy of ESPB for acute and chronic shoulder pain. However, there are no randomized clinical studies. The aim of this study is to compare the efficacy of the US-guided ESPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.

Detailed Description

Postoperative pain is an important issue in patients underwent arthroscopic shoulder surgery. Pain causes a few problems; discomfortable 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 the analgesic agents. Parenteral opioids are generally performed for 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 interscalen 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 increasily due to the advantages of ultrasound in anesthesia practice. The US-guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016. The ESPB contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level, and lumbar analgesia at T10-12, L3 levels. To the best of our knowledge, there have been a few case reports about the efficacy of ESPB for acute and chronic shoulder pain. There are no randomized clinical studies, yet.

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

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-07
• Study First Posted: 2019-09-10
• Study Start: 2020-04-26
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E = ESPB group	Erector spinae plane block (Group E)	In group E, ESPB will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T2 transvers process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted caudo-cranial direction and then for correction of the needle 5 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.
Group I = ISCB group	Interscalen brachial plexus block (Group I)	In group I, ISCB will be performed with patients in the supin position. US probe will be placed in transverse plane at the level of cricoid cartilage. The prob will be moved laterally when the artery is visualized. The needle will be inserted in a medial-to-lateral direction after the brachial plexus between the scalen muscles is visualized. Then, 5 ml normal saline will be enjected for correction of the needle with in-plane technique. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours	The primary aim is to compare perioperative and postoperative opioid consumption

Secondary Outcome Measures

Name	Time	Method
Pain scores (Visual analogue scores-VAS)	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey