- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06609590
A Comparative Study Between Anterior Glenoid Block With Sub-omohyoid Suprascapular Block Versus Interscalene Block in Shoulder Arthroscopy
A Comparative Study Between Ultrasound Guided Anterior Glenoid Block Combined With Sub-omohyoid Anterior Suprascapular Block Versus Ultrasound Guided Interscalene Block in Diagnostic Shoulder Arthroscopy
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: Patients will receive Anterior glenoid block combined with suprascapular nerve block.
Group B: Patients will receive conventional interscalene block.
In group A, the patient will be supine for anterior glenoid block.
The suprascapular nerve will be identified as it branch off from the superior trunk and will be traced until it courses beneath the inferior belly of the omohyoid muscle.
In group B, interscalene brachial plexus block will be performed.
The primary outcomes will be as follows: (1) 11-point (0-10) numeric rating scale (NRS) pain score immediately before surgery starts and after surgery; (2) degree of preserved diaphragmatic function (DPDF): the ratio of postoperative to pre-block (baseline) diaphragmatic excursion amplitude will be assessed in the holding area using a curvilinear probe (Sono Site, Transportable fuji M-turbo ultrasound system).;(3) degree of preserved handgrip strength (DPHS): the ratio of postoperative to pre-block (baseline) handgrip strength (the maximal force patients exerted when instructed to squeeze the dynamometer handles as tightly as feasible). Measurements will be done before surgery, immediately postoperative, 4, 8, and 24 hours postoperatively.
And (4) Recording of the complications which are: Hematoma, nerve injury, allergy to any of the used drugs.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Ain Shams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 65 years.
- Both sexes.
- Patients scheduled for shoulder arthroscopy.
Exclusion Criteria:
- Patient refusal
- ASA physical status III or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with history of cardiovascular disease.
- Patients with renal disease.
- Patients with hepatic disease.
- Patients with neuromuscular disease.
- Presence of any coagulopathy.
- Chronic opioid, gabapentin or pregabalin use.
- Patients with history of any psychiatric disorder.
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 |
|---|---|
|
Experimental: Group A
Patients will receive Anterior glenoid block combined with suprascapular nerve block.
|
Ultrasound guided anterior glenoid nerve block combined with Sub-omohyoid Anterior Suprascapular nerve Block
|
|
Experimental: Group B
The patients will Interscalene brachial plexus block.
|
Ultrasound guided interscalene brachial plexus block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of preserved diaphragmatic function (DPDF)
Time Frame: 24 hours postoperative.
|
degree of preserved diaphragmatic function (DPDF): the ratio of postoperative to pre-block (baseline) diaphragmatic excursion amplitude will be assessed in the holding area using a curvilinear probe (Sono Site, Transportable fuji M-turbo ultrasound system).).
Measurements will be made before surgery, immediately postoperative, 4, 8, and 24 hours postoperatively.
|
24 hours postoperative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
11-point (0-10) numeric rating scale (NRS) pain score.
Time Frame: 24 hours postoperative.
|
11-point (0-10) numeric rating scale (NRS) pain score immediately before surgery starts and after surgery.).
Measurements will be made at 4, 8, and 24 hours postoperatively.
|
24 hours postoperative.
|
|
Degree of preserved handgrip strength (DPHS)
Time Frame: 24 hours postoperative.
|
Degree of preserved handgrip strength (DPHS): the ratio of postoperative to pre-block (baseline) handgrip strength (the maximal force patients exerted when instructed to squeeze the dynamometer handles as tightly as feasible).
Measurements will be made before surgery, immediately postoperative, 4, 8, and 24 hours postoperatively.
|
24 hours postoperative.
|
|
Recording of the complications.
Time Frame: 24 hours postoperative.
|
Recording of the complications which are: Hematoma, nerve injury, allergy to any of the used drugs.
|
24 hours postoperative.
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- FAMSU R143/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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