- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07151443
- Original Trial
Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block
Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block in Obese Patients
Forearm and hand surgeries are among the most frequently performed surgical interventions both in trauma patients and electively.In these procedures, alternative anesthesia methods such as general anesthesia, regional intravenous anesthesia, regional peripheral nerve blocks and local anesthesia are available.
Peripheral nerve blockade can be used for anesthesia and analgesia.This method allows patients to undergo surgery without general anesthesia and increases patient satisfaction by providing effective analgesia in the postoperative period.
The aim of this study was to compare the conventional and retroclavicular approaches to infraclavicular block in patients undergoing forearm and hand surgery.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Musa Zengin, Associate Professor
- Phone Number: +905307716235
- Email: musazengin@gmail.com
Study Contact Backup
- Name: Ibrahim Topcu, MD
- Phone Number: +905437860316
- Email: ibrahimtpc78@gmail.com
Study Locations
-
-
Ankara
-
Yenimahalle, Ankara, Turkey (Türkiye), 06170
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- İbrahim Topcu, MD
- Phone Number: 00905437860316
- Email: ibrahimtpc78@gmail.com
-
Contact:
- Musa Zengin, Associate Professor
- Phone Number: 00905307716235
- Email: musazengin@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients 18-80 years of age
- Those with ASA score II-III
- Those with a body mass index (BMI) >30
- Patients who are suitable for forearm and hand surgery under regional anesthesia in the operating room
Exclusion Criteria:
- Patients who cannot perceive and evaluate pain
- Patients who want to have surgery under general anesthesia
- Patients in whom regional anesthesia is contraindicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional approach to infraclavicular block
After the patients are monitored and placed in the supine position, after appropriate field sterilization, Conventional approach to infraclavicular block will be performed on the patients using 25 ml of local anesthetic solution (20 ml 0.5% bupivacaine + 5 ml 2% lidocaine) under ultrasound guidance.
|
Conventional approach to infraclavicular block will be performed on the patients using 20 ml of 0.5% bupivacaine 5ml of %2 lidocaine under ultrasound guidance.
|
|
Active Comparator: Retroclavicular approach to the infraclavicular block
After the patients are monitored and placed in the supine position, after appropriate field sterilization, Retroclavicular approach to the infraclavicular block will be performed on the patients using 25 ml of local anesthetic solution (20 ml 0.5% bupivacaine + 5 ml 2% lidocaine) under ultrasound guidance.
|
Retroclavicular approach to the infraclavicular block will be performed on the patients using 20 ml of 0.5% bupivacaine 5ml of %2 lidocaine under ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Block Performance Time
Time Frame: During regional anesthesia
|
Total block performance time (from skin puncture to needle removal) will be recorded
|
During regional anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Score
Time Frame: Up to 24 hours
|
Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest and when coughing.
Pain assessment will be made at 0, 1, 6, 12, 18, and 24 hours after surgery.
|
Up to 24 hours
|
|
Patient Satisfaction
Time Frame: 1 day
|
Quality of recovery-15 (QoR-15) score was used as the satisfaction score.
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery.
The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
|
1 day
|
Collaborators and Investigators
Sponsor
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 (Estimated)
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
- AEŞH-EK-2025-006
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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