CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
NCT Number: NCT02904538
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Clermont-Ferrand, 63003, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: during the first 48 hours
Time frame: at day 1
during the first 48 hours
Time frame: at day 1
overall satisfaction regarding pain relief management (using following questionnaire : No pain - Light pain - Moderate pain - Significant pain - Excruciating pain)
Time frame: during the first 7 days after surgery.
University Hospital, Clermont-Ferrand
Other
Acronym: ADRIATIC
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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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