Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

NCT ID: NCT02526199

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group BA

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Sciatic nerve block

Epinephrine

Intervention Type DRUG

Adjuvant to perinerual block

Group BAD

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Sciatic nerve block

Epinephrine

Intervention Type DRUG

Adjuvant to perinerual block

Dexamethasone

Intervention Type DRUG

Adjuvant to perinerual block

Interventions

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Bupivacaine

Sciatic nerve block

Intervention Type DRUG

Epinephrine

Adjuvant to perinerual block

Intervention Type DRUG

Dexamethasone

Adjuvant to perinerual block

Intervention Type DRUG

Other Intervention Names

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Marcaine Adrenaline Deaxagalene

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Rasmus Wulff Hauritz

OTHER

Sponsor Role lead

Responsible Party

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Rasmus Wulff Hauritz

Consultant Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Anesthesia, Aarhus University Hospital

Aarhus, Region Midt, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2014-005383-14

Identifier Type: -

Identifier Source: org_study_id

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