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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02904538
Acronym
ADRIATIC
Enrollment
100
Registered
2016-09-19
Start date
2016-11-22
Completion date
2017-05-23
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management After Surgery

Keywords

Dexamethasone, Regional anesthesia, Front foot surgery, Metacarpal osteotomy

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.

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.

Interventions

DRUGDexamethasone
DRUGisotonic saline

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
time to the first opioids requestduring the first 48 hours

Secondary

MeasureTime frameDescription
occurrence of nausea or vomitingat day 1during the first 48 hours
overall satisfaction regarding pain relief managementat day 1overall satisfaction regarding pain relief management (using following questionnaire : No pain - Light pain - Moderate pain - Significant pain - Excruciating pain)
any significant side effectsduring the first 7 days after surgery.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026