Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Study Overview
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Brief Summary
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To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.

Official Title
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Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Epinephrine
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 17 scheduled major foot and ankle surgery written informed consent fertile women in anti conceptive treatment fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery Exclusion Criteria: patients not able to understand or cooperate allergies to medicines involved daily buse of steroids daily use of opioids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group BA<br>Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml | Drug: Bupivacaine<br>* Sciatic nerve block<br>* Other names: Marcaine;Drug: Epinephrine<br>* Adjuvant to perinerual block<br>* Other names: Adrenaline;|
| Experimental: Group BAD<br>Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg | Drug: Bupivacaine<br>* Sciatic nerve block<br>* Other names: Marcaine;Drug: Epinephrine<br>* Adjuvant to perinerual block<br>* Other names: Adrenaline;Drug: Dexamethasone<br>* Adjuvant to perinerual block<br>* Other names: Deaxagalene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Painfree period (time until first pain sensation in operated foot) | Patients are closely monitored in the PACU until first pain sensation in the operated foot. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in the operated foot, measured on a numeric rating scale (0-10) | Pain score at rest, with the operated foot elevated on a pillow, ranging from 0 [no pain] to 10 [worst possible pain] | Every 30 minuttes from the patient enters the PACU to the nerve block wears of | 
| Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot | Sensitivy score measured on a 3 point scale 0 (no sensation) (impared sensation) 2 (full or normal sensation) compared to non-operated side | Every 30 minutes from the patient enters the PACU to the sensations core reach 2 | 
| Total consumption of opioids during the length of stay | A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay | 48 hours | 
| quality of sleep first night measured on a 3 point scale | Quality of sleep measured on the morning after operation. 0 (good sleep, no interruptions) by pain from operated foot) 1 (sleep, but interruption without pain) 2 (sleep but interrupted by pain from operated foot) | hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local anesthetics, Perineural nerve blocks, Perineurial Dexamethasone