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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU Clermont-Ferrand
Clermont-Ferrand, France
Start Date
November 22, 2016
Primary Completion Date
May 23, 2017
Completion Date
May 23, 2017
Last Updated
June 16, 2017
100
ACTUAL participants
Dexamethasone
DRUG
isotonic saline
DRUG
Lead Sponsor
University Hospital, Clermont-Ferrand
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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