NCT03688269

Brief Summary

Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

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

September 14, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

October 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

September 14, 2018

Last Update Submit

December 18, 2020

Conditions

Anesthesia, ConductionRopivacaineDexamethasoneAxillary Brachial Plexus Block

Keywords

regional anesthesiadexamethasoneropivacaine

Outcome Measures

Primary Outcomes (1)

  • Surgical Effectiveness of regional anesthesia at 30min

    Ability to perform surgery under regional anaesthesia without supplementary anaesthesia

    Time of surgery

Secondary Outcomes (8)

  • time between regional anesthesia and surgical incision

    Time of surgery

  • Effectiveness of regional anaesthesia on Pin-Prick sense

    Time of anaesthesia

  • Effectiveness of regional anaesthesia on cold sensation

    Time of anaesthesia

  • Effectiveness of regional anaesthesia on motor function

    Time of anaesthesia

  • recovery of regional anesthesia: pain

    first 48h

  • +3 more secondary outcomes

Study Arms (2)

Intravenous dexamethasone

EXPERIMENTAL

Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia

Drug: Intravenous dexamethasoneDrug: Perineural ropivacaine

Intravenous saline

PLACEBO COMPARATOR

Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 2ml Saline 0.9% during the regional anesthesia

Drug: Intravenous salineDrug: Perineural ropivacaine

Interventions

Intravenous dexamethasoneDRUG

Intravenous injection of 8mg/2ml dexamethasone

Intravenous dexamethasone
Intravenous salineDRUG

Intravenous injection of 2ml Saline 0.9%

Intravenous saline
Perineural ropivacaineDRUG

Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method

Intravenous dexamethasoneIntravenous saline

Eligibility Criteria

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

You may qualify if:

  • years old or older
  • ASA Score 1,2 et 3 (American Society of Anesthesiologists Score)
  • surgery under axillary brachial plexus block
  • signed information consent

You may not qualify if:

  • pregnancy and breastfeeding
  • contraindication to regional anesthesia or technical impossibility
  • impaired coagulation
  • delay of surgery to short to allow regional anesthesia
  • dementia or under administrative supervision
  • allergy and contraindication to dexamethasone or ropivacaine
  • total dose of ropivacaine higher than 3 mg / kg (recommended dose for upper limb regional anesthesia)
  • opioids or pain killers abuse or addiction
  • steroids consumption in the past 6 months
  • surgery estimated to be greater than 4 hours
  • anticipated bad observation of treatment
  • patient enrolled in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

Study Officials

  • Francis BERTHIER

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: allocation to one of the 2 arm after randomization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 28, 2018

Study Start

October 5, 2018

Primary Completion

November 4, 2019

Study Completion

May 4, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations

FR(1)