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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Epinephrine; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Region Midt
    • Aarhus, Region Midt, Denmark, 8000
      • Department of Anesthesia, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rasmus Wulff Hauritz
• Collaborators: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Local anesthetics; Perineural nerve blocks; Perineurial Dexamethasone
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Dexamethasone; Bupivacaine; Epinephrine
• Other Study ID Numbers: 2014-005383-14