Back to resultsEfficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Primary Purpose
Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
interscalene block
superior trunk block
Sponsored by
About this trial
This is an interventional treatment trial for Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries focused on measuring superior trunk block, interscalene block
Eligibility Criteria
Inclusion Criteria: Patients American Society of Anaesthesiologists physical status (ASA) is I to II. Both genders. Aged group from 21 to 50 years old. Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile. Exclusion Criteria: Refusal of the procedure or participation in the study. Any history or evidence of coagulopathy. Evidence of infection at injection site. Allergy to study drugs. Patients with pulmonary severe respiratory disease. Herniated cervical disc or cervical myelopathy. Pre-existing neuropathy of the operative limb
Sites / Locations
- Ainshams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
interscalene block group
superior trunk block group
Arm Description
participants undergoing shoulder surgeries will receive ultrasound guided interscalene block
participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block
Outcomes
Primary Outcome Measures
diaphragmatic paralysis postoperative
o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound
Secondary Outcome Measures
analgesic efficacy
o Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score
rescue analgesia
The total amount of rescue analgesia used
Post operative nausea and vomiting
incidence of post operative complications as nausea an vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05978427
Brief Title
Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Official Title
Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries
Detailed Description
The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Keywords
superior trunk block, interscalene block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interscalene block group
Arm Type
Active Comparator
Arm Description
participants undergoing shoulder surgeries will receive ultrasound guided interscalene block
Arm Title
superior trunk block group
Arm Type
Active Comparator
Arm Description
participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block
Intervention Type
Procedure
Intervention Name(s)
interscalene block
Intervention Description
will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.
Intervention Type
Procedure
Intervention Name(s)
superior trunk block
Intervention Description
will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.
Primary Outcome Measure Information:
Title
diaphragmatic paralysis postoperative
Description
o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound
Time Frame
within 24 hours after surgery
Secondary Outcome Measure Information:
Title
analgesic efficacy
Description
o Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score
Time Frame
within 24 hours after surgery
Title
rescue analgesia
Description
The total amount of rescue analgesia used
Time Frame
within 24 hours after surgery
Title
Post operative nausea and vomiting
Description
incidence of post operative complications as nausea an vomiting
Time Frame
within 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
Both genders.
Aged group from 21 to 50 years old.
Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.
Exclusion Criteria:
Refusal of the procedure or participation in the study.
Any history or evidence of coagulopathy.
Evidence of infection at injection site.
Allergy to study drugs.
Patients with pulmonary severe respiratory disease.
Herniated cervical disc or cervical myelopathy.
Pre-existing neuropathy of the operative limb
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa N Elhanafy, msc
Phone
01110296565
Ext
002
Email
mostafaelhanafy@med.asu.edu.eg
Facility Information:
Facility Name
Ainshams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ainshams university
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
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