Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infraclavicular | Experimental | This group will receive an ultrasound-guided infraclavicular brachial plexus block. |
|
| Axillary | Active Comparator | This group will receive an ultrasound-guided axillary brachial plexus block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Procedural sedation before the execution of the block.
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of brachial plexus sensory block | q5min up to 30 min after the block |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of brachial plexus motor block | q5min up to 30 min after the block | |
| Patient satisfaction (3-point scale) | End of surgery | |
| Anesthesia-related procedural pain (0-10 numerical rating scale) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guido Fanelli, MD | Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma | Study Chair |
| Giorgio Danelli, MD | UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital / Azienda Ospedaliero-Universitaria | Parma | PR | 43100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ropivacaine | Drug | 0.75% (wt/vol) solution, 20 ml perineural injection |
|
|
| Fentanyl | Drug | 50 µg iv bolus prn for pain during surgery, up to 150 µg |
|
|
| General anesthesia | Procedure | General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg. |
|
|
| Axillary brachial plexus nerve block | Procedure | 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. |
|
|
| Infraclavicular brachial plexus block | Procedure | 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. |
|
|
| End of block placement |
| Rescue analgesic requirements during surgery | During surgery |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005543 | Forearm Injuries |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D001569 | Benzodiazepines |
| D011292 | Premedication |
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| D005283 | Fentanyl |
| D000701 | Analgesics, Opioid |
| D000700 | Analgesics |
| D000768 | Anesthesia, General |
| D000765 | Anesthesia, Conduction |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009294 | Narcotics |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
Not provided
Not provided