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Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery 42

Not yet recruiting
Clinical Trial NCT06519851 is an interventional study for Shoulder Pain and is currently not yet recruiting. Enrollment is planned to begin on 1 August 2024 and continue until the study accrues 42 participants. Led by Assiut University, this study is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 6 August 2024.
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.
Detailed Description
Significant acute postoperative pain is common in adults after shoulder surgery, with approximately 45% reporting severe pain in the immediate postoperative period. This pain may necessitate opioid use for several days. The opioid requirement may be similar to that following gastrectomy or thoracotomy, and opioid-only analgesic techniques for shoulder surgery are commonly associated with opioid-related adverse effect...Show More
Official Title

Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery: Randomized Controlled Clinical Trial

Conditions
Shoulder Pain
Other Study IDs
  • SHAC & SSNB
NCT ID Number
NCT06519851
Start Date (Actual)
2024-08
Last Update Posted
2024-08-06
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
42
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparator• SSNB & SHAC
patients 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)
suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%
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 tendo...Show More
Placebo Comparator• Interscalene
patients 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.
Interscalene block with 20 ml bupivacaine 0.25%
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively
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
Any Complications related to the blocks as hemodynamic changes, hoarseness of voice, Horner syndrome, vascular injury, sensory or motor side effects.
24 hours postoperatively
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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.

  • 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
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Study Responsible Party
Dalia Mohamed Abbas, Principal Investigator, assisstant lecturer, Assiut University
No contact data.