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Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine
Epinephrine
Dexamethasone
Sponsored by
Rasmus Wulff Hauritz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Local anesthetics, Perineural nerve blocks, Perineurial Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • Department of Anesthesia, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group BA

Group BAD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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]
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
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
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)

Full Information

First Posted
August 11, 2015
Last Updated
September 22, 2016
Sponsor
Rasmus Wulff Hauritz
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02526199
Brief Title
Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rasmus Wulff Hauritz
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Local anesthetics, Perineural nerve blocks, Perineurial Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group BA
Arm Type
Active Comparator
Arm Description
Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml
Arm Title
Group BAD
Arm Type
Experimental
Arm Description
Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Sciatic nerve block
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
Adrenaline
Intervention Description
Adjuvant to perinerual block
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Deaxagalene
Intervention Description
Adjuvant to perinerual block
Primary Outcome Measure Information:
Title
Painfree period (time until first pain sensation in operated foot)
Description
Patients are closely monitored in the PACU until first pain sensation in the operated foot.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain in the operated foot, measured on a numeric rating scale (0-10)
Description
Pain score at rest, with the operated foot elevated on a pillow, ranging from 0 [no pain] to 10 [worst possible pain]
Time Frame
Every 30 minuttes from the patient enters the PACU to the nerve block wears of
Title
Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot
Description
Sensitivy score measured on a 3 point scale 0 (no sensation) (impared sensation) 2 (full or normal sensation) compared to non-operated side
Time Frame
Every 30 minutes from the patient enters the PACU to the sensations core reach 2
Title
Total consumption of opioids during the length of stay
Description
A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay
Time Frame
48 hours
Title
quality of sleep first night measured on a 3 point scale
Description
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)
Time Frame
hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Anesthesia, Aarhus University Hospital
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

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