Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery

NCT06790732 | Completed

• 1 other identifier: 36264MS117/3/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the analgesic efficacy of preoperative ultrasound-guided peri-capsular nerve group block (PENG) on postoperative analgesia after shoulder arthroscopic surgery.

Conditions

Preoperative; Ultrasound-Guided; PeriCapsular Nerve Group Block; Postoperative Analgesia; Shoulder Arthroscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Time to the first request of rescue analgesia

  Time to the first request of rescue analgesia was recorded from the end of the surgery till first dose of morphine administrated.

  24 hours postoperatively

Secondary Outcomes (2)

• Degree of pain

  24 hours postoperatively

• Total morphine consumption

  24 hours postoperatively

Study Arms (2)

Control Group

SHAM COMPARATOR

Patients received sham PENG block (just 1mL saline).

Drug: Saline

PeriCapsular Nerve Group Block (PENG) Group

EXPERIMENTAL

Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).

Drug: Bupivacaine + Dexamethasone

Interventions

Saline DRUG

Patients received sham PENG block (just 1mL saline).

Control Group

Bupivacaine + Dexamethasone DRUG

Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).

Also known as: PeriCapsular Nerve Group Block (PENG)

PeriCapsular Nerve Group Block (PENG) Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 21 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Scheduled for unilateral shoulder arthroscopic surgery.

You may not qualify if:

• Patient refusal.
• Known hypersensitivity to local anesthetics.
• Body mass index\> 35 kg /m2.
• Uncooperative or psychiatric patients.
• Infection at the injection site.
• Coagulation disorder.
• Major cardiac, renal, or hepatic diseases.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride; Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

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: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• 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

EG (1)