NCT00497276

Brief Summary

The most useful method to manage pain after major foot and ankle surgery is infusion of local anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee joint. Inaccurate catheter placement and spread of local anesthetic account for most failures. The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve. In recent years ultrasound technique has been applied to provide real-time, visual guidance of catheter placement. The purpose of this randomized, controlled trial is to compare the success rate, patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 21, 2009

Status Verified

December 1, 2009

Enrollment Period

2.2 years

First QC Date

July 4, 2007

Last Update Submit

December 18, 2009

Conditions

Pain

Keywords

AdultsAnesthesia recovery periodComparative studyElectric stimulationHumansNerve blocks/methods/indicationsPatient satisfactionPeripheral nervesSciatic nerve/ultrasonographyUltrasonographyTreatment outcomeNerve blocks/economics

Outcome Measures

Primary Outcomes (1)

  • Success rate: post-operative analgesia

    First two post-operative days

Secondary Outcomes (7)

  • Time consumption of catheter placement

    Before surgery

  • Duration of post-operative observation

    After surgery

  • Pain score

    First two post-operative days

  • Nausea score

    First two post-operative days

  • Sensory block

    First two post-operative days

  • +2 more secondary outcomes

Study Arms (2)

I

EXPERIMENTAL

Ultrasound guided placement of popliteal catheter

Procedure: placement of popliteal catheter

II

EXPERIMENTAL

Nerve stimulation guided placement of popliteal catheter

Procedure: placement of popliteal catheter

Interventions

placement of popliteal catheterPROCEDURE

Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h

III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective posterior foot and/or ankle surgery
  • calcaneus osteotomy
  • subtalar arthrodesis
  • total ankle arthroplasty
  • ankle arthrodesis (non-arthroscopic) minimum age 18 years ASA I-III informed consent

You may not qualify if:

  • coagulation disorders
  • infection in the region of needle insertion
  • systemic infection
  • preoperative sciatic nerve neuropathy
  • preoperative motor or sensory deficit in the operative extremity
  • Charcot-Marie-Tooth disorder
  • diabetic neuropathy
  • severe peripheral vascular disease
  • allergy to local anesthetics
  • lack of understanding of the visual analogue scale
  • communication problems
  • dementia
  • body mass index above 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Aarhus University Hospital

Aarhus, DK-8000 Aarhus C, Denmark

Location

Related Publications (2)

  • Ehlers L, Jensen JM, Bendtsen TF. Cost-effectiveness of ultrasound vs nerve stimulation guidance for continuous sciatic nerve block. Br J Anaesth. 2012 Nov;109(5):804-8. doi: 10.1093/bja/aes259. Epub 2012 Jul 31.

    PMID: 22855632DERIVED

  • Bendtsen TF, Nielsen TD, Rohde CV, Kibak K, Linde F. Ultrasound guidance improves a continuous popliteal sciatic nerve block when compared with nerve stimulation. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):181-4. doi: 10.1097/aap.0b013e31820d421f.

    PMID: 21425514DERIVED

MeSH Terms

Conditions

PainPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Thomas F Bendtsen, Ph.d.

    Department of Anesthesiology, Aarhus University Hospital, Norrebrogade, DK-8000 Aarhus C, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 4, 2007

First Posted

July 6, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 21, 2009

Record last verified: 2009-12

Locations

DK(1)