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Home Infusors for Analgesia After Foot Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00600899
First received: January 14, 2008
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Hallux Valgus
Procedure: elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h
Procedure: elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Home Pumps for Analgesia After Ambulatory Foot Surgery - Comparison of Two Infusion Rates - a Randomized, Double-Blind Study

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • worst pain [ Time Frame: first postoperative day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average pain [ Time Frame: 1st, 2nd and 3rd postoperative days ] [ Designated as safety issue: Yes ]
  • Opioid consumption [ Time Frame: first, second and third postoperative days ] [ Designated as safety issue: Yes ]
  • Side effects [ Time Frame: 1st, 2nd and 3rd postoperative days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 500 ml reservoir and infusion rate of 8 ml/h)
Active Comparator: B
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
Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 275 ml reservoir and infusion rate of 5ml/h)

Detailed Description:

Protocol title:

Use of home pumps for analgesia after ambulatory foot surgery - comparison of two infusion rates SUMMARY in English

THE PURPOSE:

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.

BACKGROUND:

In the previous study (1) we showed that the continuous perisciatic infusion of 2 mg/ml ropivacaine 5 ml/h for 55 hours provided better analgesia than placebo after ambulatory foot surgery. Similar results are reported by Singelyn (2), Ilfeld (3) and White (4). But, different pumps with different basal infusion rates were used in these studies. Singelyn used infusion rate of 7 ml/h for 48 hours, while Ilfeld used mechanical pump with adjustable infusion rate, starting with 8 ml/h and patient controlled analgesia (PCA) 2 ml/20 minutes for 2 postoperative days. In our and White's studies elastomeric pumps with reservoir of 500 ml and infusion rate of 5 ml/h were used in 55 hours. Capdevila (5) has shown that the patients prefer elastomeric pumps because they cause fewer problems. That is why it will be our choice as well.

The analgesic efficacy in our study was good as the patients in the treatment group had less pain and fewer sleep disturbances than in the placebo group. The question is whether higher infusion rate and longer duration would have an even better effect.

The aim of this study is to compare (in a double blind manner) two different regimens for continuous perisciatic nerve infusion of ropivacaine 2 mg/ml after ambulatory foot surgery:

  1. elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h (duration 55 hours) and
  2. elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h (duration 62 hours).

Design:

A randomized, double blind study with 40 ambulatory patients who will undergo foot or ankle surgery. These patients will be randomized to receive either regimen 1. (5 ml/h for 55 hours) or regimen 2. (8 ml/h for 62 hours). The randomization procedure: sequentially numbered, sealed, opaque envelopes that contain computer produced random numbers for treatment allocation. Blinding procedures: pre-numbered identical containers marked with "Test drug", date of production and infusion start/end will be provided by the registered nurse (SK). The patient and the acute pain nurse (EB), who will evaluate the effect of these two treatments, will be blinded.

On each of the 3 postoperative days the patients will be contacted by phone by the acute pain nurse and a standard questionnaire will be completed.

The primary effect variable is worst pain on the first postoperative day evaluated as VAS score.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600899

Locations
Denmark
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Principal Investigator: Dusanka Zaric, MD pHd Ndr. Fasanvej 57 2000 Frederiksberg
  More Information

Publications:
Responsible Party: Dusanka Zaric, Frederiksberg Hospital
ClinicalTrials.gov Identifier: NCT00600899     History of Changes
Other Study ID Numbers: EudraCT2007-005180-10, 9445-DZ
Study First Received: January 14, 2008
Last Updated: January 28, 2009
Health Authority: Denmark: Danish Medicines Agency
United States: Food and Drug Administration

Keywords provided by Frederiksberg University Hospital:
Postoperative pain treatment

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014