Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery (ADRIATIC)

June 15, 2017 updated by: University Hospital, Clermont-Ferrand

Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia.

There is a lack of data to determine wich route allows a longer analgesic effect.

This study aims to determine wether perineural dexamethasone allows a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, double-blind controlled trial.

All Patients undergoing front foot surgery with metacarpal osteotomy will be screened for inclusion in the protocol. All patients without exclusion criteria will be included in the study.

All patients will receive 30cc mixure of Ropivacaine 0,375% in perineural injection and surgery will be performed under regional anesthesia only. If needed, a sedation with midazolam (1mg) will be performed.

The patients will be randomized over 2 groups:

  • "Perineural group":

    • 1cc (4mg) of dexamethasone will be administrated in perineural injection
    • 2.5cc of isotonic saline solution will be administrated in systemic injection

  • "Systemic group":

    • 1cc of isotonic saline will be administrated in perineural injection
    • 2.5cc (10mg) of dexamethasone will be administrated in systemic injection

For both groups perineural injection will be performed at the ankle and the following nerves will be targeted: the tibial nerve, saphenous nerve, the deep fibular nerve, the superficial fibular nerve and the sural nerve.

Post-operative analgesia will be reached with paracetamol (1gr each 6 hours) and Ketoprofen (100mg each 12 hours).

After surgery, patients will be asked to write down the time to the first opioids request during the first 48 hours, maximal pain during the first 48H using a visual analog scale, occurrence of nausea or vomiting, overall satisfaction regarding pain relief management and any significant side effects during the first 7 days.

The primary objective of the study is to determine if perineural dexamethasone is associated with a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.

The primary end-point will be time to the first opioids request during the first 48 hours.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • front foot surgery with metacarpal osteotomy under regional anesthesia
  • >18 years old
  • consent to participate in the study

Exclusion Criteria:

  • refusal to participate
  • pregnancy
  • feeding
  • pre existing neuropathy
  • ropivacaine allergy
  • paracetamol allergy
  • liver failure
  • cardiac failure
  • ketoprofen allergy
  • gastric ulcer within the previous year
  • tramadol allergy
  • history of epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perineural group
1cc (4mg) of dexamethasone will be administrated in perineural injection. 2.5cc of isotonic saline solution will be administrated in systemic injection.
Drug: Dexamethasone
Experimental: systemic group
1cc of isotonic saline will be administrated in perineural injection. 2.5cc (10mg) of dexamethasone will be administrated in systemic injection.
Drug: Dexamethasone
Drug: isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to the first opioids request
Time Frame: during the first 48 hours
during the first 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of nausea or vomiting
Time Frame: at day 1
during the first 48 hours
at day 1
overall satisfaction regarding pain relief management
Time Frame: at day 1
overall satisfaction regarding pain relief management (using following questionnaire : No pain - Light pain - Moderate pain - Significant pain - Excruciating pain)
at day 1
any significant side effects
Time Frame: during the first 7 days after surgery.
during the first 7 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2016

Primary Completion (Actual)

May 23, 2017

Study Completion (Actual)

May 23, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0277
  • 2016-001341-41 (Other Identifier: 2016-001341-41)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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