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Completed

NCT Number: NCT02526199

Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia, Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Sciatic nerve block

Other names: Marcaine

Epinephrine

Drug

Adjuvant to perinerual block

Other names: Adrenaline

Dexamethasone

Drug

Adjuvant to perinerual block

Other names: Deaxagalene

Primary outcomes

  1. Painfree period (time until first pain sensation in operated foot)

    Time frame: 48 hours

    Patients are closely monitored in the PACU until first pain sensation in the operated foot.

Secondary outcomes

  1. Pain in the operated foot, measured on a numeric rating scale (0-10)

    Time frame: 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]

  2. Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot

    Time frame: 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

  3. Total consumption of opioids during the length of stay

    Time frame: 48 hours

    A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay

  4. quality of sleep first night measured on a 3 point scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Rasmus Wulff Hauritz

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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