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Clinical Trials/NCT04081948
NCT04081948
Completed
Not Applicable

Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Pain Management Following Arthroscopic Shoulder Surgery

Medipol University1 site in 1 country60 target enrollmentSeptember 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Syndrome
Sponsor
Medipol University
Enrollment
60
Locations
1
Primary Endpoint
Opioid consumption
Status
Completed
Last Updated
5 years ago

Overview

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 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 evaluate the efficacy of the US-guided ESPB 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 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 evaluate the efficacy of the US-guided ESPB 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).

Registry
clinicaltrials.gov
Start Date
September 26, 2019
End Date
September 16, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Bahadir Ciftci

Primary researcher

Medipol University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Opioid consumption

Time Frame: 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 Outcomes

  • Pain scores (Visual analogue scores-VAS)(Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.)

Study Sites (1)

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