Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suprascapular Nerve Block
Axillary Nerve Block
posterior cord block
General anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Anesthesia DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
circumflex
posterior cord
Arm Description
patients will undergo ultrasound guided SSN+circumflex
patients will undergo ultrasound guided SSN+circumflex
Outcomes
Primary Outcome Measures
Time of the first postoperative analgesic request
Secondary Outcome Measures
Visual analogue score
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).
Total morphine consumption
Full Information
NCT ID
NCT04446403
First Posted
June 22, 2020
Last Updated
June 26, 2020
Sponsor
Bassant M. Abdelhamid
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04446403
Brief Title
Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bassant M. Abdelhamid
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the circumflex nerve which comes from the posterior cord of the brachial plexus that usually gives also upper subscapular, thoracodorsal, lower subscapular and radial nerves.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
circumflex
Arm Type
Experimental
Arm Description
patients will undergo ultrasound guided SSN+circumflex
Arm Title
posterior cord
Arm Type
Experimental
Arm Description
patients will undergo ultrasound guided SSN+circumflex
Intervention Type
Procedure
Intervention Name(s)
Suprascapular Nerve Block
Other Intervention Name(s)
SSN
Intervention Description
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) .
Intervention Type
Procedure
Intervention Name(s)
Axillary Nerve Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
posterior cord block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time of the first postoperative analgesic request
Time Frame
12 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue score
Description
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).
Time Frame
12 hours postoperative
Title
Total morphine consumption
Time Frame
12 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Zaghloul
Phone
002-01001839591
Email
a_zaghloul2000@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohsen Waheb
Phone
002-01001525602
Email
Mohsen.mwaheb@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abd-Elraouf Nasr
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Zaghloul
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Waheb
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Anesthesia Department
City
Cairo
ZIP/Postal Code
1772
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18165599
Citation
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.
Results Reference
background
PubMed Identifier
18020078
Citation
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.
Results Reference
background
PubMed Identifier
28258838
Citation
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.
Results Reference
background
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Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy
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