- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739201
ISB, SSNB, and PENG Block for Arthroscopic Shoulder Surgery
Comparative Study Between Interscalene Nerve Block, Anterior Suprascapular Nerve Block, and Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery
Study Overview
Status
Conditions
Detailed Description
Shoulder arthroscopy is a common outpatient operation with an increasing number of indications and complexity. Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient's recovery.
Nowadays, several ultrasound -guided regional anesthesia methods are used for postoperative analgesia. Regional techniques such as interscalene and supraclavicular blocks are usually preferred for shoulder analgesia. Interscalene brachial plexus block (ISB) is the gold standard technique in this area.
Suprascapular nerve block (SSB) has been proposed as an alternative to the ISB in providing analgesia for shoulder surgeries as it has a lower likelihood of causing phrenic nerve blockade.
The pericapsular nerve group (PENG) block has been suggested to be safely applied for analgesia and can be part of surgical anesthesia, but alone is not sufficient for anesthesia in shoulder surgery. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shrouk M Elsawaf, Master
- Phone Number: +20 +201091533902
- Email: Shroukms95@gmail.com
Study Locations
-
-
EL-Gharbia
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Tanta, EL-Gharbia, Egypt, 31527
- Recruiting
- Shrouk Mohamed Elsawaf
-
Contact:
- Shrouk M Elsawaf, Master
- Phone Number: +20 01091533902
- Email: Shroukms95@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients.
- ASA class I and II and scheduled for elective shoulder arthroscopy.
Exclusion Criteria:
- Patient who refuses the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- History of Pre-existing major organ dysfunction such as hepatic and renal failure.
- History of pre-existing lung disease (COPD, uncontrolled asthma).
- Preexisting upper extremity neurological abnormality or neuropathy.
- Difficulties in comprehending (NRS).
- Chronic opioid users (opioid intake more than 3 months).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (I)
30 patients will receive interscalene nerve block.
|
Patients will receive interscalene nerve block, in which the patient will be in supine position with the head turned to the contralateral side using an ultrasound scan to identify the C5 and C6 nerve roots between the scalene muscles.15
ml of 0.25% Bupivacaine will be deposited between the C5 and C6 nerve roots, within the interscalene groove using a 22 gauge-regional block needle.
|
|
Active Comparator: Group (II)
30 Patients will receive anterior suprascapular nerve block.
|
Patients will receive anterior suprascapular nerve block, in which the patient will be in supine position with the head turned to the contralateral side, using an ultrasound the nerve will be traced as it diverges from the brachial plexus to lie under the omohyoid muscle in the supraclavicular fossa.
15 ml of 0.25% Bupivacaine will be deposited lateral to the suprascapular nerve, underneath the omohyoid muscle using a 22 gauge-regional block needle.
|
|
Active Comparator: Group (III)
30 atients will receive pericapsular nerve group block around shoulder surgery
|
Patients will receive PENG block, in which the patient will be in supine position and the patient's arm will be placed in external rotation and abducted at 45 degrees, using an ultrasound the humeral head, the tendon of the subscapularis muscle and the deltoid muscle over it will be defined, 15 ml of 0.25% Bupivacaine will be placed between the deltoid muscle and subscapularis tendon using a 22 gauge-regional block needle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the total opioid consumption.
Time Frame: 24-hour postoperatively
|
Postoperative analgesia will be assessed by total opioid consumption and time till administration of first rescue analgesia will be recorded.
|
24-hour postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayman A Youssef, MD, Professor of Anaesthesiology, Surgical Intensive Care and Pain Therapy, Faculty of Medicine, Tanta University, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 36264MS18/1/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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