Preoperative Ultrasound Guided Thoracic Erector Spinae Plane Block Versus Costoclavicular Block for Shoulder Arthroscopy

April 22, 2025 updated by: Mohamed Gamal Naeem, Tanta University
This study was conducted to compare the perioperative analgesic effect of ultrasound guided high thoracic erector spinae plane block versus ultrasound guided costoclavicular block for shoulder arthroscopy

Study Overview

Detailed Description

Shoulder surgery is one of the most common orthopedic surgical procedures that causes severe pain . Pain management in such patients is very important because pain relief allows early mobilization, effective postoperative rehabilitation, and shorter hospitalization stays. Several regional anesthesia techniques have been used for pain management following shoulder surgery. Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder procedures, but this method can lead to some serious complications, such as hemidiaphragmatic paralysis (HDP), Horner's syndrome, and hoarseness.

The costoclavicular block (CCB) was introduced as infraclavicular approach, first described in 2015 , targets the brachial plexus in the costoclavicular space where its three cords are tightly clustered together lateral to the axillary artery and more superficially than with the classical approach of infraclavicular fossa . Recently, Garcia-Vittoria et al have suggested that the costoclavicular space could also serve as a retrograde channel to supraclavicular brachial plexus blocks, so if local anesthetic (LA) injected in the costoclavicular space can reliably reach the supraclavicular brachial plexus enabling reliable anesthesia including anesthesia to the suprascapular nerve during shoulder surgery, one could achieve analgesic parity with small-volume supraclavicular block (and ISB) while retaining the 0% incidence of HDP seen with infraclavicular blocks.

Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016 (. It is an interfascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 90 patients admitted for elective unilateral shoulder arthroscopy.
  • Aged (21 - 65) years.
  • American Society of Anesthesiologists (ASA) physical activity I, II

Exclusion Criteria:

  • Patient refusal.
  • Patient with neurological deficit.
  • Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant and antiplatelets drugs).
  • Uncooperative patient.
  • Infection at the block injection site.
  • Patients with history of allergy to local anaesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae plane Block group
Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2)
Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2)
Other Names:
  • Bupivacaine 0.25%
Experimental: Costoclavicular block group
Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery
Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery.
Other Names:
  • Bupivacaine 0.25%
Sham Comparator: Control group
Patients received sham block .
Patients received sham block
Other Names:
  • Sham block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Pethidine consumption
Time Frame: 24 hours postoperatively
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable") at (T 30 min, 2, 4, 6,12, 18, 24 h, non-steroidal anti-inflammatory drugs were given (ketorolac 30mg) to all patient /8 h and if VAS > 4 intravenous pethidine 0.5 mg / kg per dose.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic request after surgery
Time Frame: 24 hours postoperatively
Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) was recorded.
24 hours postoperatively
Complications
Time Frame: 24 hours postoperatively
Complications (Hematoma, pneumothorax, persistent numbness/ paraesthesia or motor deficit one week after the surgery) were recorded.
24 hours postoperatively
Degree of pain
Time Frame: 24 hours postoperatively
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable") at (T 30 min, 2, 4, 6,12, 18, 24 h, non-steroidal anti-inflammatory drugs were given (ketorolac 30mg) to all patient /8 h and if VAS > 4 intravenous pethidine 0.5 mg / kg per dose.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

March 29, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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