- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796778
Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block
Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block for Postoperative Shoulder Surgery Pain: Randomized Comparative Study.
Shoulder surgery can be very painful surgery after which the use of opioids is often required. The well-known side-effects of opioids (e.g. respiratory depression, somnolence, nausea, vomiting, and pruritus) limit their use in so called 'fast track' surgery and anaesthesia programmes.
the study aimed to compare the effect of sub omohyoid suprascapular nerve block versus interscalene nerve block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for shoulder surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: hassan m. hetta, lecturer
- Phone Number: 0020 1010901114
- Email: hassan.hetta@mu.edu.eg
Study Locations
-
-
-
Minya, Egypt, 61511
- Recruiting
- Minia University Hospital
-
Contact:
- hassan m. hetta, lecturer
- Phone Number: 0020 1010901114
- Email: hassan.hetta@mu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-60 years.
- ASA I-II.
- Both sexes.
- Shoulder surgery.
Exclusion Criteria:
- Patient refusal
- Allergy to local anesthetics
- BMI >40 kg/m2
- Bleeding diathesis or history of anticoagulant use.
- Psychiatric diseases.
- Infection of the skin at the site of needle punctures area.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interscalene brachial plexus
ultrasound-guided interscalene block involves imaging the C5 and C6 roots at approximately the level of the cricoid cartilage, just distal to where they emerge from behind their respective transverse processes and where they lie in the groove between the anterior and middle scalene muscles
|
The block needle is usually advanced in plane in a lateral-to-medial direction through the middle scalene muscle to contact the nerve roots and inject local anesthetic around them.
|
|
Experimental: subomohyoid suprascapular nerve
superficial probe of ultrasound was placed in the transverse plane to visualize the superior trunk in the short axis.
The suprascapular nerve was identified as it branched off from the superior trunk and traced until it coursed beneath the inferior belly of the omohyoid muscle.
|
The block needle was inserted in line with the probe in a lateral-to-medial orientation toward the suprascapular nerve.
Local anesthetic solution was then injected after negative aspiration for blood to achieve circumferential spread around the neurovascular bundle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue pain score
Time Frame: 24 hour
|
pain score from 0 to 10 which mean 0 no pain and 10 the worst pain ever
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of first analgesic request
Time Frame: 24 hour
|
the time of first demand rescue analgesia
|
24 hour
|
|
Total analgesic consumption
Time Frame: 24 hour
|
total fentanyl demand
|
24 hour
|
|
Incidence of any side effects
Time Frame: 24 hour
|
oxygen desaturation, pneumothorax, dyspnea, and phrenic nerve palsy, block, and opioid-related side effects
|
24 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: hassan m. hetta, lecturer, minia university/ faculty of medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 685/2023
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
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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