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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02904538
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Pain Management After Surgery Drug: Dexamethasone Drug: isotonic saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery
Actual Study Start Date : November 22, 2016
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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



Primary Outcome Measures :
  1. time to the first opioids request [ Time Frame: during the first 48 hours ]

Secondary Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904538


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02904538    
Other Study ID Numbers: CHU-0277
2016-001341-41 ( Other Identifier: 2016-001341-41 )
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Clermont-Ferrand:
Dexamethasone
Regional anesthesia
Front foot surgery
Metacarpal osteotomy
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents