Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
Primary Purpose
Upper Extremity, Orthopedic Surgery, Trauma
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Midazolam
Ropivacaine
Fentanyl
General anesthesia
Axillary brachial plexus nerve block
Infraclavicular brachial plexus block
Sponsored by
About this trial
This is an interventional treatment trial for Upper Extremity focused on measuring Anesthesia, Upper extremity, Nerve block, Ultrasound, Brachial plexus
Eligibility Criteria
Inclusion Criteria:
- ASA Physical Status Class <4
- Scheduled upper extremity orthopedic surgery
Exclusion Criteria:
- Psychiatric or cognitive disorder
- Allergy to study drugs
- Contraindication to nerve block at the assigned site
Sites / Locations
- University Hospital / Azienda Ospedaliero-Universitaria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Infraclavicular
Axillary
Arm Description
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
This group will receive an ultrasound-guided axillary brachial plexus block.
Outcomes
Primary Outcome Measures
Onset time of brachial plexus sensory block
Secondary Outcome Measures
Onset of brachial plexus motor block
Patient satisfaction (3-point scale)
Anesthesia-related procedural pain (0-10 numerical rating scale)
Rescue analgesic requirements during surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724035
Brief Title
Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
Official Title
Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Parma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.
Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.
The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.
Detailed Description
Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.
A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.
The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity, Orthopedic Surgery, Trauma, Forearm Injuries, Nerve Block
Keywords
Anesthesia, Upper extremity, Nerve block, Ultrasound, Brachial plexus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infraclavicular
Arm Type
Experimental
Arm Description
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Arm Title
Axillary
Arm Type
Active Comparator
Arm Description
This group will receive an ultrasound-guided axillary brachial plexus block.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed, Benzodiazepine, Premedication, Sedation
Intervention Description
Procedural sedation before the execution of the block.
0.03 mg/kg iv bolus
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin, Local anesthetic, Amide local anesthetic
Intervention Description
0.75% (wt/vol) solution, 20 ml perineural injection
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Opioid, Analgesic
Intervention Description
50 µg iv bolus prn for pain during surgery, up to 150 µg
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Other Intervention Name(s)
Monitored anesthesia care
Intervention Description
General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.
Intervention Type
Procedure
Intervention Name(s)
Axillary brachial plexus nerve block
Other Intervention Name(s)
Peripheral Nerve Block, Regional Anesthesia, Ultrasound
Intervention Description
Blocks will be performed under high-resolution real-time ultrasound guidance.
Patients will be in the supine position. With the abducted arm flexed 90° at the elbow, the transducer will scan for the axillary artery in its short-axis. Individual nerves will be sought for around the artery.
A 22G, 17°-bevel needle will be advanced in-plane to inject aliquots of local anesthetic around each nerve structure up to the prescribed dose.
Intervention Type
Procedure
Intervention Name(s)
Infraclavicular brachial plexus block
Other Intervention Name(s)
Regional Anesthesia, Peripheral nerve block, Ultrasound
Intervention Description
Blocks will be performed under high-resolution real-time ultrasound guidance.
Patients will be in the supine position. The linear transducer will be initially positioned between the middle and lateral third of the clavicle, scanning on a parasagittal plane.
The axillary artery and veins will then be sought for. We will try to visualize the three cords of the brachial plexus separately, and to inject local anesthetic around each of them. If this is not possible, the needle will be positioned cranially and posteriorly to the artery, and the injection will be made from there. A 20 G, 17°-bevel needle will be used for all blocks.
Primary Outcome Measure Information:
Title
Onset time of brachial plexus sensory block
Time Frame
q5min up to 30 min after the block
Secondary Outcome Measure Information:
Title
Onset of brachial plexus motor block
Time Frame
q5min up to 30 min after the block
Title
Patient satisfaction (3-point scale)
Time Frame
End of surgery
Title
Anesthesia-related procedural pain (0-10 numerical rating scale)
Time Frame
End of block placement
Title
Rescue analgesic requirements during surgery
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA Physical Status Class <4
Scheduled upper extremity orthopedic surgery
Exclusion Criteria:
Psychiatric or cognitive disorder
Allergy to study drugs
Contraindication to nerve block at the assigned site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Fanelli, MD
Organizational Affiliation
Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giorgio Danelli, MD
Organizational Affiliation
UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital / Azienda Ospedaliero-Universitaria
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
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Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
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