Trial | NCT02526199  Report issue

Title

Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
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.
Study Started
Aug 31
2015
Primary Completion
Jul 31
2016
Study Completion
Jul 31
2016
Last Update
Sep 23
2016
Estimate

Drug Bupivacaine

Sciatic nerve block

  • Other names: Marcaine

Drug Epinephrine

Adjuvant to perinerual block

  • Other names: Adrenaline

Drug Dexamethasone

Adjuvant to perinerual block

  • Other names: Deaxagalene

Group BA Active Comparator

Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml

Group BAD Experimental

Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg

Criteria 

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
No Results Posted