NCT07689045

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress34%
Jun 2026Nov 2026

Study Start

First participant enrolled

June 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2026

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 30, 2026

Last Update Submit

July 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) Pain Score at Rest at 24 Hours Postoperatively

    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.

    24 hours after surgery

Secondary Outcomes (2)

  • Visual Analog Scale (VAS) Pain Scores at Postoperative Time Points

    multiple postoperative time points.

  • Total opioid consumption

    during the first 24 hours.

Study Arms (2)

Modified PENG + Suprascapular Nerve Block (SSNB)

EXPERIMENTAL

Participants receive an ultrasound-guided Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) before induction of general anesthesia for elective Bankart repair or Latarjet surgery. The Modified PENG Block is performed with 20 mL of 0.25% bupivacaine and the SSNB with 10 mL of 0.25% bupivacaine.

Procedure: • Modified PENG Block combined with Suprascapular Nerve Block

Interscalene Brachial Plexus Block (ISB)

ACTIVE COMPARATOR

Participants receive an ultrasound-guided Interscalene Brachial Plexus Block (ISB) using 20 mL of 0.25% bupivacaine before induction of general anesthesia for elective Bankart repair or Latarjet surgery

Procedure: • Interscalene Brachial Plexus Block

Interventions

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

Modified PENG + Suprascapular Nerve Block (SSNB)

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

Interscalene Brachial Plexus Block (ISB)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • History of allergy to local anesthetics.
  • Chronic opioid use (\>3 months).
  • Coagulation disorders.
  • Pre-existing neurological or musculoskeletal disorders.
  • Respiratory compromise (e.g., COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine , Cairo University Hospitals

Cairo, Cairo Governorate, Egypt

RECRUITING

Study Officials

  • Ahmed Zaghloul Foaad, Professor of Anaesthesia

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Hamza Ibrahem Mohamed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecture

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 29, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because there is no plan for public data sharing. Only aggregated study results will be reported in scientific publications while maintaining participant confidentiality.Individual participant data will not be shared because there is no plan for public data sharing. Only aggregated study results will be reported in scientific publications while maintaining participant confidentiality.

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