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

Perioperative Pain Clinical Trial

Official title:

Comparative Study Between Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation, Double Blinded Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034873
• Other study ID #: RC 17-7-2023
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: Benha University
• Contact: Fatma Ah Abdelfatah, MD
• Phone: 01027011148
• Email: drfatmaahmed86[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. In an ideal scenario, the surgeon could achieve complete pain control and muscle relaxation without compromising the patient's airway. There are various techniques available to facilitate shoulder reduction, including interscalene block, general anesthesia, and intravenous analgesia. All of these methods can help the surgeon ease the patient's pain and reduce the likelihood of complications.1 When choosing the anesthesia method for reducing ASD, the top priority is ensuring the patient's comfort through pain management. The anesthesia helps to relax the muscle spasms, making it easier to reduce the ASD. The goal is to relocate the shoulder with minimal risk of complications.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• (ASA )classes I and II

• patients of either sex, above the age of 18

• patients will undergo dislocated shoulder

Exclusion Criteria:

• the patient's refusal to participate

• coagulation disorders

• allergy to local anesthetic

• history of daily opioid intake

• patients with cognitive impairments

Related Conditions & MeSH terms

• Perioperative Pain
• Shoulder Dislocation

Intervention

Drug:
• Propofol injection and 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.
• Bupivacain
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.

Locations

Country	Name	City	State
Egypt	Banha faculity of medicine	Banha	Elqalyoubea

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay	the period when the patient stayed in the hospital	1st 24 hours
Secondary	reduction time	the period from the beginning to the end of reduction	1st hour after intervetion
Secondary	the visual analogue scale(VAS)	ranges from 0 to 10, with 0 representing no pain and 10 being the most intense pain possible.	30 minutes ,2,4,8,12 hours postoperative