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NCT Number: NCT02346110

Protracted Effect of the Ultrasound-guided Saphenous Block

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.

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Key information

Conditions

Arthrosis, Unspecified, Ankle and Foot Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bupivacaine-adrenaline

Drug

50 mg bupivacaine and 50 μg adrenalin

Other names: Marcain-adrenalin

Dexamethasone

Drug

4 mg

Other names: Dexagalen

Sodium Chloride

Other

1 mL of sodium chloride solution as placebo

Other names: NaCL

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Acronym: PEUSB

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Feb 12, 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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