- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02397330
is There an Alternative to Ultrasound Guided Interscalene Block?
March 23, 2015 updated by: Dr trabelsi walid, Tunisian Military Hospital
the Association of Ultrasound Guided Suprascapular and Supraclavicular Nerve Block Provides Adequate Analgesia in Comparison With Ultrasound Guided Interscalene Block
Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery.
However, this technique would have side effects and potential serious complications.
The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA physical status I-III
- 18-75 years of age, inclusive
- shoulder surgery (LATARJET technique)
Exclusion Criteria:
- contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit
- pregnancy
- history of neck surgery or radiotherapy
- severe respiratory disease
- inability to understand the informed consent and demands of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group BIS
scheduled for ultrasound guided interscalene blockade with 30 ml of bupivacaine 0.25%
|
ultrasound guided nerve blocks
|
Experimental: group BS
scheduled for selective blockade of the ultrasound guided suprascapular (15 ml bupivacaine 0.25%) and supraclavicular (15 ml bupivacaine 0.25%) nerves blocks
|
ultrasound guided nerve blocks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogic Scale
Time Frame: until 48 hours postoperative
|
quality of postoperative analgesia
|
until 48 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total dose of morphine consumption in mg
Time Frame: during 48 hours post operative
|
during 48 hours post operative
|
|
time to perform the blocks
Time Frame: up to 5 minutes
|
up to 5 minutes
|
|
patient satisfaction
Time Frame: 48 hours post performing nerves blocks
|
scale from 0 (not satisfied at all) to 100 (full satisfaction)
|
48 hours post performing nerves blocks
|
occurrence of complications
Time Frame: 48 hours post performing nerves blocks
|
48 hours post performing nerves blocks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
May 1, 2015
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TunisianMH1
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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