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Protracted Effect of the Ultrasound-guided Saphenous Block (PEUSB)

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ClinicalTrials.gov Identifier: NCT02346110
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
This study focuses on optimizing the postoperative pain treatment after major foot and ankle surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently used single shot saphenous block only covers half of the pain intensive period from the saphenous territory, which results in a sharp, break-through pain requiring opioids. The hypothesis is that this protracted mixture will keep the patients free of pain without the use of opioids for the entire pain intensive period and thus increase rehabilitation and patients' satisfaction.

Condition or disease Intervention/treatment Phase
Arthrosis, Unspecified, Ankle and Foot Drug: Bupivacaine-adrenaline Drug: Dexamethasone Other: Sodium chloride Phase 4

Detailed Description:

Half of the patients will receive a single shot saphenous block with 10 mL bupivacaine-adrenalin and 1 mL of sodium chloride solution, while the other half will receive 10 mL of bupivacaine-adrenalin and 1 mL of dexamethasone.

The block is strictly a sensory block because it is a selective, sub-sartorial saphenous block at mid-thigh level without any anesthetic effect on the femoral nerve.

The adjuvant dexamethasone has increasingly become a subject of interest regarding a protracted effect, which has been shown in several studies. However, the precise mechanism of action remains speculative, and the results are contradictory regarding the discussion whether the effect is systemic or local. The effect may stem from decreased nociceptive C-fibre activity via a direct action on glucocorticoid receptors and inhibitory potassium channels. Another suggestion is a vasoconstrictive effect, which reduces the systemic uptake of local anaesthetics or a systemic anti-inflammatory effect.

Prolonging the effect of the single shot saphenous block by adding dexamethasone will reduce the need for opioids, which will reduce the risk of adverse effects like nausea, vomiting and respiratory depression. Furthermore, newer studies show that inadequate pain alleviation in the early postoperative period is a risk factor in developing chronic persistent pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Effect of a Single Shot Saphenous Block With Plain Bupivacaine vs. Protracted Bupivacaine Mixture as a Supplement to Continuous Sciatic Catheter After Major Ankle and Foot Surgery
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Bupivacaine-adrenalin + sodium chloride

Single shot saphenous block:

10 mL of 5 mg/mL bupivacaine with 5 μg/mL adrenalin = 50 mg bupivacain and 50 μg adrenalin

1 mL sodium chloride solution

Drug: Bupivacaine-adrenaline
50 mg bupivacaine and 50 μg adrenalin
Other Name: Marcain-adrenalin

Other: Sodium chloride
1 mL of sodium chloride solution as placebo
Other Name: NaCL

Experimental: Bupivacaine-adrenaline + Dexamethasone

Single shot saphenous block:

10 mL of 5 mg/mL bupivacaine with 5 μg/mL adrenalin = 50 mg bupivacain and 50 μg adrenalin

1 mL of 4 mg/mL dexamethasone = 4 mg dexamethasone

Drug: Bupivacaine-adrenaline
50 mg bupivacaine and 50 μg adrenalin
Other Name: Marcain-adrenalin

Drug: Dexamethasone
4 mg
Other Name: Dexagalen




Primary Outcome Measures :
  1. Duration of the saphenous nerve block [ Time Frame: 48 hours ]
    The duration is registered as the time until the first dose of morphine is taken, and when the pain score is above 3 and located to the frontal or medial side of the ankle. Morphine is administered intravenously by a patient controlled pump (PCA - Patient Controlled Analgesia)


Secondary Outcome Measures :
  1. Cumulated opioid consumption [ Time Frame: 48 hours ]
    Registered by the PCA pump

  2. Pain score [ Time Frame: Arrival at the Perioperative Section which will be within 30 minutes after surgery. Departure from the Perioperative Section which is expected to be on average 2 hours after surgery. 6, 12, 24, 30, 36, 42 and 48 hours after surgery ]
    NRS (numeric rating scale)

  3. Pain localization [ Time Frame: Arrival at the Perioperative Section which will be within 30 minutes after surgery. Departure from the Perioperative Section which is expected to be on average 2 hours after surgery. 6, 12, 24, 30, 36, 42 and 48 hours after surgery ]
    Lateral or medial side of the ankle

  4. Test of sensory block [ Time Frame: Arrival at the Perioperative Section which will be within 30 minutes after surgery. Departure from the Perioperative Section which is expected to be on average 2 hours after surgery. 6, 12, 24, 30, 36, 42 and 48 hours after surgery ]

    The sensory block of the peroneal nerve is tested on the dorsal side of the toes and the tibial nerve on the plantar side of the toes.

    The ankle and lower leg is covered in cast, and therefore the saphenous nerve is tested around the tibial tuberosity because this area is innervated by the infra-patellar nerve, which is a branch of the saphenous nerve




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis
  • Age ≥ 18
  • American Society of Anaesthesiology Classification I-III
  • Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

Exclusion Criteria:

  • Communication problems or dementia
  • Allergies to any medical product used in the study
  • Neuropathy of the sciatic or femoral nerve prior to the operation
  • Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
  • BMI > 35
  • Pregnancy
  • Daily use of opioids
  • Coagulation disorders
  • Infection at the site of injection or systemic infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346110


Locations
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Denmark
Department of Anesthesiology, Aarhus University Hospital
Aarhus, Midtjylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Thomas Fichtner Bendtsen, MD, phD Department of Anesthesiology, Aarhus University Hospital
Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02346110    
Other Study ID Numbers: ProtokolSB1
2014-004207-78 ( EudraCT Number )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Dexamethasone
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action