- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913140
Preoperative Ultrasound Guided Thoracic Erector Spinae Plane Block Versus Costoclavicular Block for Shoulder Arthroscopy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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:
|
|
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:
|
|
Sham Comparator: Control group
Patients received sham block .
|
Patients received sham block
Other Names:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35844/9/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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