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

Pain Management After Surgery Clinical Trial

— ADRIATIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904538
• Other study ID #: CHU-0277
• Secondary ID: 2016-001341-41
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2016
• Last updated: June 15, 2017
• Start date: November 22, 2016
• Est. completion date: May 23, 2017

Study information

• Verified date: June 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Management After Surgery

Intervention

Drug:
• Dexamethasone

• isotonic saline

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to the first opioids request		during the first 48 hours
Secondary	occurrence of nausea or vomiting	during the first 48 hours	at day 1
Secondary	overall satisfaction regarding pain relief management	overall satisfaction regarding pain relief management (using following questionnaire : No pain - Light pain - Moderate pain - Significant pain - Excruciating pain)	at day 1
Secondary	any significant side effects		during the first 7 days after surgery.