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

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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

Tracking Information
First Submitted Date  ICMJE September 6, 2023
First Posted Date  ICMJE September 13, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date  ICMJE September 15, 2023
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2023)		 length of hospital stay [ Time Frame: 1st 24 hours ]
the period when the patient stayed in the hospital
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2023)
  • reduction time [ Time Frame: 1st hour after intervetion ]
    the period from the beginning to the end of reduction
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2023)
  • reduction time [ Time Frame: 1st hour after intervetion ]
    the period from the beginning to the reduction
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation
Official Title  ICMJE Comparative Study Between Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation, Double Blinded Controlled Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Perioperative Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Propofol injection and fentanyl
  • Active Comparator: Group B
    Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
    Intervention: Drug: Bupivacain
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2023)		 42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2024
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fatma Ah Abdelfatah, MD 01027011148 drfatmaahmed86@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06034873
Other Study ID Numbers  ICMJE RC 17-7-2023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fatma Ahmed Abdel Fatah, Benha University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Benha University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fatma Ah Abdelfatah, MD banha faculity of medicine
PRS Account Benha University
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP