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Completed

NCT Number: NCT02904538

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Isotonic saline

Drug

Primary outcomes

  1. time to the first opioids request

    Time frame: during the first 48 hours

Secondary outcomes

  1. occurrence of nausea or vomiting

    Time frame: at day 1

    during the first 48 hours

  2. 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)

  3. any significant side effects

    Time frame: during the first 7 days after surgery.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: ADRIATIC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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