NCT06765278

Brief Summary

This study aims to compare between Anterior glenoid nerve block, pericapsular nerve group (PENG) block and Interscalene brachial plexus (ISB) block for post-operative pain management in shoulder arthroscopic surgeries

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 31, 2024

Last Update Submit

January 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Time to the first request for the rescue analgesia (time from the end of surgery to the first dose of pethidine administrated).

    24 hours postoperatively

Secondary Outcomes (5)

  • Total pethidine consumption

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Length of hospital stay

    Till discharge from hospital (Up to one week).

  • Time needed for the patient to freely move the operated limb

    Postoperatively (Up to one week).

  • Degree of patients satisfaction

    24 hours postoperatively

Study Arms (3)

Interscalene brachial plexus block group

ACTIVE COMPARATOR

Patients will receive an Interscalene brachial plexus block.

Other: Interscalene brachial plexus block

Anterior glenoid nerve block group

EXPERIMENTAL

Patients will receive an anterior glenoid nerve block.

Other: Anterior glenoid nerve block

Pericapsular nerve group (PENG) block group

EXPERIMENTAL

Patients will receive a pericapsular nerve group (PENG) block.

Other: Pericapsular nerve group block

Interventions

Patients will receive an Interscalene brachial plexus block.

Interscalene brachial plexus block group

Patients will receive an anterior glenoid nerve block.

Anterior glenoid nerve block group

Patients will receive a pericapsular nerve group (PENG) block.

Pericapsular nerve group (PENG) block group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 70 years.
  • No sex predilection.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Undergoing shoulder arthroscopic surgeries.

You may not qualify if:

  • Patient's refusal.
  • Patients with a history of drug allergies to study drugs.
  • Evidence of local infection at the site of injection.
  • Inability to cooperate
  • Neuromuscular pathology (example: - Multiple Sclerosis)
  • Previous trauma or surgery to the shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Mohamed Serry, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anaesthesia, Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 9, 2025

Study Start

January 13, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations