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Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Upper Extremity Orthopedic Surgery Trauma Forearm Injuries Nerve Block | Drug: Midazolam Drug: Ropivacaine Drug: Fentanyl Procedure: General anesthesia Procedure: Axillary brachial plexus nerve block Procedure: Infraclavicular brachial plexus block | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial |
- Onset time of brachial plexus sensory block [ Time Frame: q5min up to 30 min after the block ]
- Onset of brachial plexus motor block [ Time Frame: q5min up to 30 min after the block ]
- Patient satisfaction (3-point scale) [ Time Frame: End of surgery ]
- Anesthesia-related procedural pain (0-10 numerical rating scale) [ Time Frame: End of block placement ]
- Rescue analgesic requirements during surgery [ Time Frame: During surgery ]
| Estimated Enrollment: | 52 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Infraclavicular
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
|
Drug: Midazolam
Procedural sedation before the execution of the block.
Other Names:
Drug: Ropivacaine
0.75% (wt/vol) solution, 20 ml perineural injection
Other Names:
Drug: Fentanyl
50 µg iv bolus prn for pain during surgery, up to 150 µg
Other Names:
Procedure: General anesthesia
General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.
Other Name: Monitored anesthesia care
Procedure: Infraclavicular brachial plexus block
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. Other Names:
|
|
Active Comparator: Axillary
This group will receive an ultrasound-guided axillary brachial plexus block.
|
Drug: Midazolam
Procedural sedation before the execution of the block.
Other Names:
Drug: Ropivacaine
0.75% (wt/vol) solution, 20 ml perineural injection
Other Names:
Drug: Fentanyl
50 µg iv bolus prn for pain during surgery, up to 150 µg
Other Names:
Procedure: General anesthesia
General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.
Other Name: Monitored anesthesia care
Procedure: Axillary brachial plexus nerve block
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. Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00724035
| Italy | |
| University Hospital / Azienda Ospedaliero-Universitaria | |
| Parma, PR, Italy, 43100 | |
| Study Chair: | Guido Fanelli, MD | Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma |
| Principal Investigator: | Giorgio Danelli, MD | UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma |
More Information
| Responsible Party: | Guido Fanelli, MD, University of Parma |
| ClinicalTrials.gov Identifier: | NCT00724035 History of Changes |
| Other Study ID Numbers: |
ANEST-ORT-02 |
| Study First Received: | July 25, 2008 |
| Last Updated: | July 14, 2009 |
Keywords provided by University of Parma:
|
Anesthesia Upper extremity Nerve block Ultrasound Brachial plexus |
Additional relevant MeSH terms:
|
Forearm Injuries Arm Injuries Wounds and Injuries Anesthetics Fentanyl Ropivacaine Midazolam Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Opioid Narcotics Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 17, 2017