NCT00600899

Brief Summary

The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

1.2 years

First QC Date

January 14, 2008

Last Update Submit

January 28, 2009

Conditions

Hallux Valgus

Keywords

Postoperative pain treatment

Outcome Measures

Primary Outcomes (1)

  • worst pain

    first postoperative day

Secondary Outcomes (3)

  • Average pain

    1st, 2nd and 3rd postoperative days

  • Opioid consumption

    first, second and third postoperative days

  • Side effects

    1st, 2nd and 3rd postoperative days

Study Arms (2)

A

EXPERIMENTAL

Group A patients will receive perisciatic continuous infusion of ropivacaine 2 mg/ml through an elastomeric pump (Baxter, Deerfield, IL, USA)) 8 ml/h (reservoir of 500 ml)as postoperative analgesia.

Procedure: elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h

B

ACTIVE COMPARATOR

Group B patients will receive standard treatment: continuous perisciatic infusion of 2 mg/ml ropivacaine 5 ml/t (Baxter infusor with 275 ml reservoir)

Procedure: elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h

Interventions

elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/hPROCEDURE

Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 500 ml reservoir and infusion rate of 8 ml/h)

A
elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/hPROCEDURE

Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 275 ml reservoir and infusion rate of 5ml/h)

B

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All ambulatory patients (ASA 1-3) scheduled for foot and ankle surgery in spinal or general anesthesia that are willing to participate in the study after informed consent will be taken into consideration.
  • Age span: 19 -80 years.
  • When fertile females are included, we will make sure that they receive anticonceptive treatment.

You may not qualify if:

  • Contraindications for sciatic catheter placement and allergy to local anesthetics.
  • The patients with chronic pain receiving opioids, pregnant patients, those with rheumatoid arthritis, lever or heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

  • Zaric D, Boysen K, Christiansen J, Haastrup U, Kofoed H, Rawal N. Continuous popliteal sciatic nerve block for outpatient foot surgery--a randomized, controlled trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):337-41. doi: 10.1111/j.0001-5172.2004.0327.x.

    PMID: 14982567BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Dusanka Zaric, MD pHd

    Ndr. Fasanvej 57 2000 Frederiksberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

DK(1)