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

NCT01445210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-10-19

No results posted yet for this study

Summary

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.

Conditions

  • Major Ankle Surgery

Interventions

PROCEDURE

Continuous saphenous nerve block

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

PROCEDURE

Placebo

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Thomas F Bendtsen, ph.d., MD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445210 on ClinicalTrials.gov