- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034873
Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation
Comparative Study Between Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation, Double Blinded Controlled Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Elqalyoubea
-
Banhā, Elqalyoubea, Egypt, 13511
- Banha Faculity of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
|
Active Comparator: Group B
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
|
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of hospital stay
Time Frame: 1st 24 hours
|
the period when the patient stayed in the hospital
|
1st 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes ,2,4,8,12 hours postoperative
|
|
reduction time
Time Frame: 1st hour after intervetion
|
the period from the beginning to the end of reduction
|
1st hour after intervetion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Ah Abdelfatah, MD, Banha Faculity of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Shoulder Injuries
- Musculoskeletal Diseases
- Wounds and Injuries
- Joint Diseases
- Joint Dislocations
- Shoulder Dislocation
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Anilides
- Amides
- Aniline Compounds
- Amines
- Piperidines
- Phenols
- Benzene Derivatives
- Bupivacaine
- Propofol
- Fentanyl
Other Study ID Numbers
- RC 17-7-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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