Skip to main content
OpenTrials
Completed

NCT Number: NCT01445210

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Ankle Surgery 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

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Continuous saphenous nerve block

Procedure

0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours

Other names: Naropin

Placebo

Procedure

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

Primary outcomes

  1. Accumulated opioid consumption

    Time frame: First 48 hours postoperative

Secondary outcomes

  1. Success rate for saphenous nerve analgesia

    Time frame: Postoperative, first 48 hours

    Pain rated by NRS and opioid consumption

  2. Success rate for clinical analgesia of foot and ankle

    Time frame: Postoperative, first 48 hours

    Pain rated by NRS and opioid consumption

  3. Success rate for tibial and peroneal nerve block

    Time frame: Postoperative, first 48 hours

    Pain rated by NRS and test of sensation on the toes

  4. Localisation of worst pain

    Time frame: Postoperative, first 48 hours

  5. Cost-effectiveness

    Time frame: 2 first postoperative days

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2011
Registry last updated
Oct 19, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.