- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446403
Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy
Analgesic Effect of Ultrasound Guided Combined (Suprascapular and Circumflex Nerve Blocks ) Versus (Suprascapular Nerve and Posterior Cord Nerve Blocks at Infraclavicular Level ) During Shoulder Arthroscopy : A Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord blocks at infraclavicular level .
Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and scheduled for shoulder surgeries will be included in the study. Patients will be randomly allocated using computer-generated table into one of two groups:
- Group circumflex → will undergo ultrasound guided SSN+circumflex.
- Group posterior cord → will undergo ultrasound guided SSN+posterior cord.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Zaghloul
- Phone Number: 002-01001839591
- Email: a_zaghloul2000@yahoo.com
Study Contact Backup
- Name: Mohsen Waheb
- Phone Number: 002-01001525602
- Email: Mohsen.mwaheb@yahoo.com
Study Locations
-
-
-
Cairo, Egypt, 1772
- Recruiting
- Anesthesia Department
-
Contact:
- Bassant abdelhamid
- Phone Number: 01224254012
- Email: bassantmohamed197@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I-II.-III
- Undergoing shoulder arthroscopy.
Exclusion Criteria:
- Patient refusal
- Known allergy to local anesthetics
- Bleeding disorders
- Inability to provide informed consent
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 |
---|---|
Experimental: circumflex
patients will undergo ultrasound guided SSN+circumflex
|
The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula.
The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch.
A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
Other Names:
Patient will be put in sitting position, with the shoulder in full adduction.
linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.
General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg,
fentanyl 2-3 µ/kg and atracurium 0.5mg/kg.
maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
|
Experimental: posterior cord
patients will undergo ultrasound guided SSN+circumflex
|
The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula.
The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch.
A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
Other Names:
General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg,
fentanyl 2-3 µ/kg and atracurium 0.5mg/kg.
maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable.
The needle will be inserted in plane from the cephalad end of the probe.
10 mL bupivacaine 0.25% will be injected at the posterior cord.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of the first postoperative analgesic request
Time Frame: 12 hours postoperative
|
12 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue score
Time Frame: 12 hours postoperative
|
visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) and verbal pain scale (VPS )ranging from 0 to 3 (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain).
|
12 hours postoperative
|
Total morphine consumption
Time Frame: 12 hours postoperative
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12 hours postoperative
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohamed Abd-Elraouf Nasr, Cairo University
- Study Director: Ahmed Zaghloul, Cairo University
- Study Director: Mohsen Waheb, Cairo University
Publications and helpful links
General Publications
- Axelsson K, Gupta A, Johanzon E, Berg E, Ekback G, Rawal N, Enstrom P, Nordensson U. Intraarticular administration of ketorolac, morphine, and ropivacaine combined with intraarticular patient-controlled regional analgesia for pain relief after shoulder surgery: a randomized, double-blind study. Anesth Analg. 2008 Jan;106(1):328-33, table of contents. doi: 10.1213/01.ane.0000297297.79822.00.
- Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. doi: 10.1177/0310057X0703500418.
- Lyons C, Herring AA. Ultrasound-guided axillary nerve block for ED incision and drainage of deltoid abscess. Am J Emerg Med. 2017 Jul;35(7):1032.e3-1032.e7. doi: 10.1016/j.ajem.2017.01.064. Epub 2017 Feb 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- S-10-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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