- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04669639
A Comparison of ESP Block to SSN Block for Analgesia in Shoulder Surgery
A Comparison of Erector Spinae Plane Block to Suprascapular Nerve Block for Analgesia in Shoulder Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zagazig, Egypt, 44519
- Faculty of medicine, Zagazig university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I and II,
- Age above 21 years and below 60 years in both sexes,
- Cooperative patients,
- Patients with a BMI (body mass index) not exceeding 35.
Exclusion Criteria:
- patients with cardiovascular or respiratory compromise,
- Patient refusal,
- Coagulopathy,
- Local tissue infection,
- Allergy to local anesthesia,
- prior to cervical or thoracic spine surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The block group (a)
Patients were randomized in a 1:1 :1ratio, group (a) will receive SSN.
The nerve blocks The procedure will be performed after induction of anaesthesia and endotracheal intubation.
|
The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.
|
Experimental: The block group (b)
Patients were randomized in a 1:1:1 ratio.
group (b) will receive the Erector spinae plane block.
The procedure will be performed after induction of anesthesia and endotracheal intubation.
|
The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.
|
Placebo Comparator: control group
Patients were randomized in a 1:1:1 ratio.
this group will receive general anesthesia (GA) only
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The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative analgesia
Time Frame: The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated
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Recording of the patients' hemodynamics (heart rate and non-invasive blood pressure) and total dose of opioids consumption intraoperatively and postoperatively.
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The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Ma W, Sun L, Ngai L, Costouros JG, Steffner R, Boublik J, Tsui BCH. Motor-sparing high-thoracic erector spinae plane block for proximal humerus surgery and total shoulder arthroplasty surgery: clinical evidence for differential peripheral nerve block? Can J Anaesth. 2019 Oct;66(10):1274-1275. doi: 10.1007/s12630-019-01442-4. Epub 2019 Jul 9. No abstract available.
- Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.
- Abdelhaleem NF, Abdelatiff SE, Abdel Naby SM. Comparison of Erector Spinae Plane Block at the Level of the Second Thoracic Vertebra With Suprascapular Nerve Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery. Pain Physician. 2022 Nov;25(8):577-585.
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
Other Study ID Numbers
- #6506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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