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Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01445210
First received: September 29, 2011
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.

Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.

Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.

The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.


Condition Intervention
Major Ankle Surgery
 Procedure: Continuous saphenous nerve block
Procedure: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Accumulated opioid consumption [ Time Frame: First 48 hours postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success rate for saphenous nerve analgesia [ Time Frame: Postoperative, first 48 hours ] [ Designated as safety issue: No ]
    Pain rated by NRS and opioid consumption

  • Success rate for clinical analgesia of foot and ankle [ Time Frame: Postoperative, first 48 hours ] [ Designated as safety issue: No ]
    Pain rated by NRS and opioid consumption

  • Success rate for tibial and peroneal nerve block [ Time Frame: Postoperative, first 48 hours ] [ Designated as safety issue: No ]
    Pain rated by NRS and test of sensation on the toes

  • Localisation of worst pain [ Time Frame: Postoperative, first 48 hours ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 2 first postoperative days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0,2% Ropivacaine

Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours.

All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.

 Procedure: Continuous saphenous nerve block
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Other Name: Naropin
Placebo Comparator: Control

Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours.

All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.

 Procedure: Placebo
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours

Detailed Description:

Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).

Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.

Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.

The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Elective major ankle surgery

  • total ankle arthroplasty
  • subtalar fusion
  • ankle fusion (non arthroscopic)

Exclusion Criteria:

  • coagulation abnormalities
  • infection in the region of needle insertion
  • systemic infection
  • preoperative consumption of high dose opioid
  • preoperative sciatic or femoral nerve neuropathy
  • preoperative sensory deficit in either of the lower extremities
  • Charcot-Marie-Tooth disorder
  • diabetic neuropathy
  • severe peripheral vascular disease
  • allergy to local anesthetics
  • lack of understanding of Numeric Rank Scale (NRS)
  • communication problems
  • dementia
  • body mass index above 35
  • bilateral continuous sciatic nerve block
  • lack of consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445210

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Thomas F Bendtsen, ph.d., MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01445210     History of Changes
Other Study ID Numbers: 2011-0184
Study First Received: September 29, 2011
Last Updated: October 18, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Postoperative pain
Major ankle surgery
Continuous nerve block
Saphenous nerve
Ropivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013