Surgery
Conditions
Brief summary
Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block. The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.
Interventions
PROCEDUREmedian nerve block
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Ascending dose model
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* aged 18 years from 18 to 80 years with an ASA (American Society of Anesthesiologists) physical status I-II * elective hand ambulatory surgery with a maximum duration of 30 minutes involving the median nerve and performed with elbow nerve blocks
Exclusion criteria
* pregnant or lactating women, * contra-indication to regional anesthesia * diabetes mellitus, * effective anticoagulation or antiplatelet therapy, laboratory evidence of abnormal bleeding * neurological disease ( including carpal tunnel syndrome or neuromuscular disease detected by preoperative neurological examination in the median nerve) * infection at the puncture site * contra-indication to the administration of lidocaine, notably allergy * contra-indication to the administration of lidocaine with epinephrine * not speaking French Exclusion from the study: * patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal effective volume of local anesthetic | 1 hour | Effective volume of local anesthetic to obtain a successful median nerve block block in 95% of patients defined as complete light touch block at the palmar aspect of the 2 distal phalanges of the index finger during a 30 minute evaluation period (mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of the median nerve block | 1 hour | Success rate concerns: * success rate of sensitive block: complete cold and light touch block at 30 min and 45 min at the palmar aspect of the 2 distal phalanges of the index finger and on the thenar eminence * success rate of motor block: complete motor block at 30 min and 45 min |
| Additional local anesthetic | 2 hours | * Percentage of cases where additional local anesthetic was necessary before the incision (%), i.e; performed by anesthesiologist * Percentage of cases where additional local anesthetic was necessary after the incision (%), i.e; performed by surgeon |
| Duration of analgesia | 1 day | Time to first analgesic requirement (minutes) |
| Nerve block onset time | 1 hour | Onset time for complete cold light touch and motor block at 30 min and 45 min. |
| Complications | 1 month | * complications occurring during the procedure (pain, paresthesia, intraneural injection and vascular puncture), * complications noticed at the first postoperative month (residual pain, paresthesia, dysesthesia, weakness) |
| Block procedure time | One hour | Time taken to perform hydrodissection with dextrose 5% and inject the local anesthetic (min) |
| Duration of the block | 1 day | Delay between the completion of the block and the returned to normal onset of sensory and motor recovery of the first three fingers of the hand) (minutes) |
Countries
France
Outcome results
None listed