Back to resultsPain Control After Arthroscopic Shoulder Surgeries
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-guided Interscalene Block group
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria: Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery. Exclusion Criteria: Patient refusal. Uncooperative patient. Patient with neurological deficit. Patients with respiratory disorders. Patient with bleeding disorders. Infection at the block injection site. Patients with history of allergy to local anesthetics.
Sites / Locations
- Faculty of Medicine Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1 Ultrasound-guided Interscalene Block group
group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
Arm Description
In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.
, ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.
Outcomes
Primary Outcome Measures
post operative analgesic consumption
The first 24 hours post operative analgesic consumption
Secondary Outcome Measures
Visual Analogue score (VAS) in the first 24 hours after surgery
- Postoperative pain intensity will be assessed in the first 24 hour using VAS score where (0 = no pain and 100 = the worst imaginable pain)
Patient satisfaction score
Patient satisfaction score will be assessed on the basis of a questionnaire and graded on a 4-point scale (excellent/good/fair/poor).
The incidence of hemi diaphragmatic paralysis
hemidiaphragmatic paralysis after block
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05686395
Brief Title
Pain Control After Arthroscopic Shoulder Surgeries
Official Title
Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta 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
This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1 Ultrasound-guided Interscalene Block group
Arm Type
Active Comparator
Arm Description
In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.
Arm Title
group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
Arm Type
Active Comparator
Arm Description
, ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Interscalene Block group
Intervention Description
ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery
Intervention Type
Procedure
Intervention Name(s)
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
Intervention Description
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
bupivacaine 0.25%.
Primary Outcome Measure Information:
Title
post operative analgesic consumption
Description
The first 24 hours post operative analgesic consumption
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Visual Analogue score (VAS) in the first 24 hours after surgery
Description
- Postoperative pain intensity will be assessed in the first 24 hour using VAS score where (0 = no pain and 100 = the worst imaginable pain)
Time Frame
first 24 hours after surgery
Title
Patient satisfaction score
Description
Patient satisfaction score will be assessed on the basis of a questionnaire and graded on a 4-point scale (excellent/good/fair/poor).
Time Frame
first 24 hours after surgery
Title
The incidence of hemi diaphragmatic paralysis
Description
hemidiaphragmatic paralysis after block
Time Frame
immediately before block and immediately after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.
Exclusion Criteria:
Patient refusal.
Uncooperative patient.
Patient with neurological deficit.
Patients with respiratory disorders.
Patient with bleeding disorders.
Infection at the block injection site.
Patients with history of allergy to local anesthetics.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HOSAMELDIN ELDIB, MASTER
Phone
00201000504087
Email
dr.semsem337@gmail.com
Facility Information:
Facility Name
Faculty of Medicine Tanta University
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hosameldin eldib, master
Phone
00201000504087
Email
dr.semsem337@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Control After Arthroscopic Shoulder Surgeries
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