NCT05788367

Brief Summary

The aim of this study is to compare PENG and ISB after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

January 12, 2023

Last Update Submit

February 11, 2026

Conditions

Interscalene Nerve BlockShoulder ArthroscopyPericapsular Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Asses The postoperative opioid consumption

    the postoperative opioid consumption during the procedure

    24 hours postoperatively

Study Arms (2)

The pericapsular nerve group

ACTIVE COMPARATOR

patients received Ultrasound guided The pericapsular nerve group block using 20 ml of bupivacaine 0.5%

Procedure: The pericapsular nerve group

Interscalene group

ACTIVE COMPARATOR

patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia.

Procedure: Interscalene brachial plexus block

Interventions

The pericapsular nerve groupPROCEDURE

patients received Ultrasound guided pericapsular nerve group block using 20 ml of bupivacaine 0.5%

The pericapsular nerve group
Interscalene brachial plexus blockPROCEDURE

patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia

Interscalene group

Eligibility Criteria

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

You may qualify if:

  • Body mass index \< 40 kg/m2
  • American Society of Anesthesiologists (ASA) physical status I-II
  • posted for elective shoulder arthroscopy

You may not qualify if:

  • Known allergy to local anesthetics
  • allergy to all opioid medications
  • diagnostic shoulder arthroscopic procedures
  • patients with chronic opioids use and coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Fouad Mohamed Algyar

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

Study Officials

  • Mohammed F Algyar, MD

    Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

Study Record Dates

First Submitted

January 12, 2023

First Posted

March 28, 2023

Study Start

July 15, 2023

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be provided under a reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
One year after the end of the study

Locations

EG(1)