Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation

NCT06034873 | Completed Phase 2

• 1 other identifier: RC 17-7-2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

When someone experiences a shoulder dislocation, it can be extremely painful. Emergency physicians often choose to use conscious sedation to help reduce the pain. However, some patients may not be able to tolerate conscious sedation due to concerns about their ability to breathe properly or the risk of inhaling fluids. A recently developed technique called Ultrasound-guided Pericapsular Nerve Group (PENG) block is used to block the articular branches of the shoulder and the pericapsular spread around the glenohumeral joint. The PENG block is commonly used in hip surgery and is effective in providing motor-sparing analgesic results.

Conditions

Perioperative Pain

Outcome Measures

Primary Outcomes (1)

• length of hospital stay

  the period when the patient stayed in the hospital

  1st 24 hours

Secondary Outcomes (2)

• reduction time

  1st hour after intervetion

• the visual analogue scale(VAS)

  30 minutes ,2,4,8,12 hours postoperative

Study Arms (2)

Group A

ACTIVE COMPARATOR

In the IVAS group, the patients intravenous propofol combined with fentanyl. The sequence will be to inject fentanyl 1 μg•kg-1•min-1 first within 1 min and then inject propofol 2 mg•kg-1•min-1.

Drug: Propofol injection and fentanyl

Group B

ACTIVE COMPARATOR

Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.

Drug: Bupivacain

Interventions

Bupivacain DRUG

Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.

Also known as: markain

Group B

Propofol injection and fentanyl DRUG

The sequence will be to inject fentanyl 1 μg•kg-1•min-1 first within 1 min and then inject propofol 2 mg•kg-1•min-1.

Also known as: deprivan

Group A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (ASA )classes I and II
• patients of either sex, above the age of 18
• patients will undergo dislocated shoulder

You may not qualify if:

• the patient's refusal to participate
• coagulation disorders
• allergy to local anesthetic
• history of daily opioid intake
• patients with cognitive impairments

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha faculity of medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

MeSH Terms

Interventions

Propofol; Fentanyl; Bupivacaine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Fatma Ah Abdelfatah, MD

  banha faculity of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: November 15, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2023-10

Locations

EG (1)