Back to resultsUltrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation
Primary Purpose
Perioperative Pain
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Propofol injection and fentanyl
Bupivacain
Sponsored by
About this trial
This is an interventional treatment trial for Perioperative Pain
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
Sites / Locations
- Banha faculity of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
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.
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
Outcomes
Primary Outcome Measures
length of hospital stay
the period when the patient stayed in the hospital
Secondary Outcome Measures
reduction time
the period from the beginning to the end of reduction
the visual analogue scale(VAS)
ranges from 0 to 10, with 0 representing no pain and 10 being the most intense pain possible.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06034873
Brief Title
Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Propofol injection and fentanyl
Other Intervention Name(s)
deprivan
Intervention Description
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
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
markain
Intervention Description
Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
Primary Outcome Measure Information:
Title
length of hospital stay
Description
the period when the patient stayed in the hospital
Time Frame
1st 24 hours
Secondary Outcome Measure Information:
Title
reduction time
Description
the period from the beginning to the end of reduction
Time Frame
1st hour after intervetion
Title
the visual analogue scale(VAS)
Description
ranges from 0 to 10, with 0 representing no pain and 10 being the most intense pain possible.
Time Frame
30 minutes ,2,4,8,12 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Ah Abdelfatah, MD
Phone
01027011148
Email
drfatmaahmed86@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Ah Abdelfatah, MD
Organizational Affiliation
banha faculity of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha faculity of medicine
City
Banhā
State/Province
Elqalyoubea
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Ah Abdelfataah, MD
Phone
00201027011148
Email
drfatmaahmed86@gmail.com
12. IPD Sharing Statement
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Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation
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