The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06034873
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Fatma Ahmed Abdel Fatah, Benha University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Perioperative Pain Drug: Propofol injection and fentanyl Drug: Bupivacain Phase 2

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 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.
 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.
Other Name: deprivan
Active Comparator: Group B
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
 Drug: Bupivacain
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
Other Name: markain


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. length of hospital stay [ Time Frame: 1st 24 hours ]
    the period when the patient stayed in the hospital


Secondary Outcome Measures :
  1. reduction time [ Time Frame: 1st hour after intervetion ]
    the period from the beginning to the end of reduction

  2. the visual analogue scale(VAS) [ Time Frame: 30 minutes ,2,4,8,12 hours postoperative ]
    ranges from 0 to 10, with 0 representing no pain and 10 being the most intense pain possible.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034873


Contacts
Layout table for location contacts
Contact: Fatma Ah Abdelfatah, MD 01027011148 drfatmaahmed86@gmail.com

Locations
Layout table for location information
Egypt
Banha faculity of medicine Recruiting
Banhā, Elqalyoubea, Egypt, 13511
Contact: Fatma Ah Abdelfataah, MD    00201027011148    drfatmaahmed86@gmail.com   
Sponsors and Collaborators
Benha University
Investigators
Layout table for investigator information
Principal Investigator: Fatma Ah Abdelfatah, MD banha faculity of medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fatma Ahmed Abdel Fatah, lecturer, Benha University
ClinicalTrials.gov Identifier: NCT06034873    
Other Study ID Numbers: RC 17-7-2023
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Fentanyl
Bupivacaine
Propofol
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia