MedPath

Ultrasound-guided Nerve Block: Determination of the Minimal Effective Volume of Local Anesthetic

Phase 2
Completed
Conditions
Surgery
Interventions
Procedure: median nerve block
Registration Number
NCT02438657
Lead Sponsor
Hopital Foch
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
median nerve blockmedian nerve blockAn ultrasound-guided nerve block with dextrose 5% hydrodissection is performed in each case. The first patient will receive a 2 mL local anesthetic solution. For following patients, the volume of local anesthetic depends on the clinical result of the previous patient: * increase of the volume (0.5 mL) in case of failure, * no change or decrease (0.5 mol) in case of success; a randomization is made in this case (BCD method, Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics 2002;58:171-7)
Primary Outcome Measures
NameTimeMethod
Minimal effective volume of local anesthetic1 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 Outcome Measures
NameTimeMethod
Success rate of the median nerve block1 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

Duration of the block1 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)

Nerve block onset time1 hour

Onset time for complete cold light touch and motor block at 30 min and 45 min.

Complications1 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 timeOne hour

Time taken to perform hydrodissection with dextrose 5% and inject the local anesthetic (min)

Additional local anesthetic2 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 analgesia1 day

Time to first analgesic requirement (minutes)

Trial Locations

Locations (2)

Hopital privé de l'Ouest Parisien

🇫🇷

Trappes, France

Centre Hospitalier de la Côte Basque

🇫🇷

Bayonne, France

© Copyright 2025. All Rights Reserved by MedPath