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

NCT ID: NCT06034873

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-10-01

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.

Detailed 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.

Conditions

Perioperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

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.

Group Type: ACTIVE_COMPARATOR

Propofol injection and fentanyl

Intervention Type: 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.

Group B

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

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Bupivacain

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

Intervention Type: DRUG

Other Intervention Names

deprivan; markain

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ahmed Abdel Fatah

lecturer of anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Ah Abdelfatah, MD

Role: PRINCIPAL_INVESTIGATOR

banha faculity of medicine

Locations

Banha faculity of medicine

Banhā, Elqalyoubea, Egypt

Countries

Egypt

Other Identifiers

RC 17-7-2023

Identifier Type: -

Identifier Source: org_study_id