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

February 11, 2016 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8000
        • Department of Anesthesiology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Marcain-adrenalin
Other: Sodium chloride
1 mL of sodium chloride solution as placebo
Other Names:
  • 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 Names:
  • Marcain-adrenalin
Drug: Dexamethasone
4 mg
Other Names:
  • Dexagalen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulated opioid consumption
Time Frame: 48 hours
Registered by the PCA pump
48 hours
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)
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Thomas Fichtner Bendtsen, MD, phD, Department of Anesthesiology, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProtokolSB1
  • 2014-004207-78 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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