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

Surgery Clinical Trial

— VMAL  

Official title:

Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438657
• Other study ID #: 2014/07
• Secondary ID: 2014-000571-50
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 21, 2015
• Est. completion date: November 30, 2018

Study information

• Verified date: July 2020
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• median nerve block

Locations

Country	Name	City	State
France	Centre Hospitalier de la Côte Basque	Bayonne
France	Hopital privé de l'Ouest Parisien	Trappes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal effective volume of local anesthetic	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)	1 hour
Secondary	Nerve block onset time	Onset time for complete cold light touch and motor block at 30 min and 45 min.	1 hour
Secondary	Success rate of the median nerve block	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	1 hour
Secondary	Additional local anesthetic	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	2 hours
Secondary	Duration of analgesia	Time to first analgesic requirement (minutes)	1 day
Secondary	Duration of the block	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)	1 day
Secondary	Complications	complications occurring during the procedure (pain, paresthesia, intraneural injection and vascular puncture),; complications noticed at the first postoperative month (residual pain, paresthesia, dysesthesia, weakness)	1 month
Secondary	Block procedure time	Time taken to perform hydrodissection with dextrose 5% and inject the local anesthetic (min)	One hour