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

NCT02904538 | Completed Phase 3

• 2 other identifiers: CHU-02772016-001341-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management After Surgery

Keywords

Dexamethasone; Regional anesthesia; Front foot surgery; Metacarpal osteotomy

Outcome Measures

Primary Outcomes (1)

• time to the first opioids request

  during the first 48 hours

Secondary Outcomes (3)

• occurrence of nausea or vomiting

  at day 1

• overall satisfaction regarding pain relief management

  at day 1

• any significant side effects

  during the first 7 days after surgery.

Study Arms (2)

Perineural group

EXPERIMENTAL

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

Drug: Dexamethasone

systemic group

EXPERIMENTAL

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

Interventions

Dexamethasone DRUG

Perineural group; systemic group

isotonic saline DRUG

systemic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Marty P, Rontes O, Chassery C, Vuillaume C, Basset B, Merouani M, Marquis C, Bataille B, Chaubard M, Mailles MC, Ferre F, Delbos A. Perineural Versus Systemic Dexamethasone in Front-Foot Surgery Under Ankle Block: A Randomized Double-Blind Study. Reg Anesth Pain Med. 2018 Oct;43(7):732-737. doi: 10.1097/AAP.0000000000000769.

  PMID: 29630032 DERIVED

MeSH Terms

Interventions

Dexamethasone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jean-Michel CONSTANTIN

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 19, 2016
• Study Start: November 22, 2016
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

FR (1)