NCT02862327

Brief Summary

Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Dec 2016

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

July 22, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2017

Completed
Last Updated

January 31, 2018

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

July 22, 2016

Last Update Submit

January 30, 2018

Conditions

Postoperative PainAnesthesiaForearm Injuries

Keywords

anaesthetic techniquesregional anesthesiabrachial plexus blockLocal Anestheticropivacaineanalgesiasteroiddexamethasoneplaceboadjuvantultrasound guided

Outcome Measures

Primary Outcomes (1)

  • Analgesia duration after axillary brachial plexus block

    time to first pain at surgical site, an average of 24 hours

Secondary Outcomes (3)

  • Motor block duration after axillary brachial plexus block Safety

    up to block recovery, an average of 24 hours

  • Sensory block duration after axillary brachial plexus block

    up to block recovery, an average of 24 hours

  • incidence of adverse event

    6 month

Study Arms (2)

intravenous dexamethasone

ACTIVE COMPARATOR

intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia

Drug: intravenous dexamethasoneDrug: perineural ropivacaineOther: ultrasound guidance

intravenous placebo

PLACEBO COMPARATOR

intravenous injection of 2ml of NaCl 0.9% during regional anesthesia

Drug: intravenous placeboDrug: perineural ropivacaineOther: ultrasound guidance

Interventions

intravenous dexamethasoneDRUG

intravenous injection of dexamethasone

Also known as: DEXAMETHASONE MYLAN code UCD 9223084 3400892230849
intravenous dexamethasone
intravenous placeboDRUG

intravenous injection of placebo

intravenous placebo
perineural ropivacaineDRUG

brachial plexus block with perineural injection of Ropivacaine in the axillary fossa

intravenous dexamethasoneintravenous placebo
ultrasound guidanceOTHER

ultrasound guidance for brachial plexus block in the axillary fossa

intravenous dexamethasoneintravenous placebo

Eligibility Criteria

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

You may qualify if:

  • ASA 1,2 et 3
  • surgery under axillary brachial plexus block
  • aged \>18 years
  • signed information consent

You may not qualify if:

  • impaired coagulation
  • contraindication to regional anesthesia or technical impossibility
  • opioids or pain killers abuse or addiction
  • steroids consumption in the past 6 months
  • dementia or under administrative supervision
  • delay of surgery to short to allow regional anesthesia
  • pregnancy and breastfeeding
  • allergy and contraindication to dexamethasone or ropivacaine
  • anticipated bad observation of treatment
  • patient enrolled in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Besancon

Besançon, 25000, France

Location

Related Publications (1)

  • Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3):e100035. doi: 10.1136/rapm-2018-100035.

    PMID: 30777900DERIVED

MeSH Terms

Conditions

Pain, PostoperativeForearm InjuriesAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArm InjuriesWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 11, 2016

Study Start

December 1, 2016

Primary Completion

March 16, 2017

Study Completion

September 16, 2017

Last Updated

January 31, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)