Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2024
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 6, 2024
August 1, 2024
10 months
July 6, 2024
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery.
Visual analogue scale consists of a 10 centimeter line, with two end points representing 0 (no pain) and 10 (worst imaginable pain)
Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.
Secondary Outcomes (2)
The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively
24 hours postoperatively
Any Complications related to the blocks
24 hours postoperatively
Study Arms (2)
• SSNB & SHAC
ACTIVE COMPARATORpatients will receive general anesthesia + ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space)
• Interscalene
PLACEBO COMPARATORpatients will receive general anesthesia + ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus.
Interventions
postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) following shoulder surgery by ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space)
postoperative analgesic effect of Interscalene block (ISB) following shoulder surgery by ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus
Eligibility Criteria
You may qualify if:
- Patients of both genders
- patients aged 18-65 years
- BMI of less than 30
- American Society of Anesthesiologists (ASA) physical status I-II,
- Patients scheduled for unilateral shoulder surgery under general anesthesia.
You may not qualify if:
- Patient refusal
- BMI of 30 or more
- ASA III or more
- Pregnancy or breast feeding
- Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
- Shoulder revision surgery
- Pre-existing neurological deficits or neuropathy
- Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, coagulopathy
- Patients with chest problems not eligible for ISB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisstant lecturer
Study Record Dates
First Submitted
July 6, 2024
First Posted
July 25, 2024
Study Start
August 1, 2024
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
August 6, 2024
Record last verified: 2024-08