NCT02438657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 surgery

Timeline
Completed

Started May 2015

Typical duration for phase_2 surgery

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

May 21, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

May 6, 2015

Last Update Submit

July 21, 2020

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Nerve block onset time

    1 hour

  • Success rate of the median nerve block

    1 hour

  • Additional local anesthetic

    2 hours

  • Duration of analgesia

    1 day

  • Duration of the block

    1 day

  • +2 more secondary outcomes

Study Arms (1)

median nerve block

EXPERIMENTAL

An 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)

Procedure: median nerve block

Interventions

median nerve blockPROCEDURE
Also known as: lidocaine with epinephrine (20 mg/ml)
median nerve block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier de la Côte Basque

Bayonne, 64100, France

Location

Hopital privé de l'Ouest Parisien

Trappes, 78190, France

Location

Related Publications (1)

  • Dufour E, Jaziri S, Novillo MA, Aubert L, Chambon A, Kutz R, Vallee A, Fischler M. A randomized trial to determine the minimum effective lidocaine volume for median nerve block using hydrodissection. Sci Rep. 2022 Jan 7;12(1):52. doi: 10.1038/s41598-021-03660-7.

    PMID: 34996918DERIVED

MeSH Terms

Interventions

LidocaineEpinephrine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Eric Dufour, MD

    Centre Hospitalier de la Côte Basque, 64100 Bayonne, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Ascending dose model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

May 21, 2015

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

FR(2)