Shoulder Instability
Conditions
Brief summary
This randomized controlled trial aims to compare the analgesic efficacy and safety of a Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) versus Interscalene Brachial Plexus Block (ISB) in adult patients undergoing elective Bankart repair or Latarjet surgery under general anesthesia. Seventy patients will be randomized to receive either Modified PENG plus SSNB or ISB. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 24 hours. Secondary outcomes include opioid consumption, time to first rescue analgesia, functional recovery, range of motion, and block-related complications including respiratory compromise, motor weakness, Horner syndrome, hoarseness, and local anesthetic systemic toxicity. This randomized controlled trial aims to compare the analgesic efficacy and safety of a Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) versus Interscalene Brachial Plexus Block (ISB) in adult patients undergoing elective Bankart repair or Latarjet surgery under general anesthesia. Seventy patients will be randomized to receive either Modified PENG plus SSNB or ISB. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 24 hours. Secondary outcomes include opioid consumption, time to first rescue analgesia, functional recovery, range of motion, and block-related complications including respiratory compromise, motor weakness, Horner syndrome, hoarseness, and local anesthetic systemic toxicity.
Detailed description
Shoulder stabilization procedures such as Bankart repair and the Latarjet procedure are associated with significant postoperative pain. The interscalene brachial plexus block is considered the standard regional anesthetic technique but is associated with complications including phrenic nerve paralysis and motor weakness. This study evaluates whether a Modified PENG Block combined with Suprascapular Nerve Block can provide comparable postoperative analgesia while reducing block-related complications. This is a prospective, single-center, randomized controlled trial involving 70 ASA I-II adult patients undergoing elective shoulder stabilization surgery at Kasr Al-Ainy Hospital, Cairo University. Participants will be randomly allocated to receive either Modified PENG plus SSNB or ISB before general anesthesia. Pain scores, opioid consumption, time to first rescue analgesia, functional recovery, hemodynamic parameters, and adverse events will be assessed during the first 24 postoperative hours and during follow-up according to the study protocol
Interventions
PROCEDURE• Modified PENG Block combined with Suprascapular Nerve Block
Ultrasound-guided Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) performed before induction of general anesthesia. The Modified PENG Block is performed with 20 mL of 0.25% bupivacaine and the SSNB with 10 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective Bankart repair or Latarjet surgery
PROCEDURE• Interscalene Brachial Plexus Block
Ultrasound-guided Interscalene Brachial Plexus Block performed before induction of general anesthesia using 20 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective Bankart repair or Latarjet surgery
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to treatment allocation. Randomization will be performed using computer-generated random numbers and sealed opaque envelopes. The anesthesiologist performing the block will not be blinded because of the nature of the intervention
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: Modified PENG Block combined with Suprascapular Nerve Block (SSNB) or Interscalene Brachial Plexus Block (ISB). Participants remain in their assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* • Male or female patients aged 18 to 65 years. * Patients undergoing elective Bankart repair or Latarjet surgery. * American Society of Anesthesiologists (ASA) physical status I or II. Exclusion • Patient refusal. * History of allergy to local anesthetics. * Chronic opioid use (\>3 months). * Coagulation disorders. * Pre-existing neurological or musculoskeletal disorders. * Respiratory compromise (e.g., COPD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score at Rest at 24 Hours Postoperatively | 24 hours after surgery | Pain intensity at rest will be assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain), 24 hours after surgery. Higher scores indicate worse pain. The primary comparison is between the Modified PENG Block combined with Suprascapular Nerve Block and the Interscalene Brachial Plexus Block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores at Postoperative Time Points | multiple postoperative time points. | Pain intensity will be assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. Scores will be recorded at multiple postoperative time points. |
| Total opioid consumption | during the first 24 hours. | — |
Countries
Egypt
Contacts
CONTACTAhmed Hamza Ibrahem Mohamed, MD
PRINCIPAL_INVESTIGATORAhmed Zaghloul Foaad, Professor of Anaesthesia
Cairo University
Outcome results
None listed