Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Sponsor

Rasmus Wulff Hauritz (Other)

Overall Status

Completed

CT.gov ID

NCT02526199

Collaborator

Aarhus University Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Bupivacaine Drug: Epinephrine Drug: Dexamethasone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group BA Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml	Drug: Bupivacaine Sciatic nerve block Other Names: Marcaine Drug: Epinephrine Adjuvant to perinerual block Other Names: Adrenaline
Experimental: Group BAD Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg	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

Arm

Intervention/Treatment

Active Comparator: Group BA

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

Drug: Bupivacaine

Sciatic nerve block

Other Names:

Marcaine

Drug: Epinephrine

Adjuvant to perinerual block

Other Names:

Adrenaline

Experimental: Group BAD

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

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

Outcome Measures

Primary Outcome Measures

Painfree period (time until first pain sensation in operated foot) [48 hours]
Patients are closely monitored in the PACU until first pain sensation in the operated foot.

Secondary Outcome Measures

Pain in the operated foot, measured on a numeric rating scale (0-10) [Every 30 minuttes from the patient enters the PACU to the nerve block wears of]
Pain score at rest, with the operated foot elevated on a pillow, ranging from 0 [no pain] to 10 [worst possible pain]
Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot [Every 30 minutes from the patient enters the PACU to the sensations core reach 2]
Sensitivy score measured on a 3 point scale 0 (no sensation) (impared sensation) 2 (full or normal sensation) compared to non-operated side
Total consumption of opioids during the length of stay [48 hours]
A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay
quality of sleep first night measured on a 3 point scale [hours]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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