Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

NCT02526199 | Completed Phase 4

• 1 other identifier: 2014-005383-14
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Local anesthetics; Perineural nerve blocks; Perineurial Dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• Total consumption of opioids during the length of stay

  48 hours

• quality of sleep first night measured on a 3 point scale

  hours

Study Arms (2)

Group BA

ACTIVE COMPARATOR

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

Drug: Bupivacaine; Drug: Epinephrine

Group BAD

EXPERIMENTAL

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

Drug: Bupivacaine; Drug: Epinephrine; Drug: Dexamethasone

Interventions

Bupivacaine DRUG

Sciatic nerve block

Also known as: Marcaine

Group BA; Group BAD

Epinephrine DRUG

Adjuvant to perinerual block

Also known as: Adrenaline

Group BA; Group BAD

Dexamethasone DRUG

Adjuvant to perinerual block

Also known as: Deaxagalene

Group BAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients not able to understand or cooperate
• allergies to medicines involved
• daily buse of steroids
• daily use of opioids

Sponsors & Collaborators

• Rasmus Wulff Hauritz: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Anesthesia, Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Anesthesia

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

DK (1)