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
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|
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:
- 1cc (4mg) of dexamethasone will be administrated in perineural injection
- 2.5cc of isotonic saline solution will be administrated in systemic injection
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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: isotonic saline
- time to the first opioids request [ Time Frame: during the first 48 hours ]
- occurrence of nausea or vomiting [ Time Frame: at day 1 ]during the first 48 hours
- 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)
- any significant side effects [ Time Frame: during the first 7 days after surgery. ]
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
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Jean-Michel CONSTANTIN||University Hospital, Clermont-Ferrand|