Home Infusors for Analgesia After Foot Surgery

Use of Home Pumps for Analgesia After Ambulatory Foot Surgery - Comparison of Two Infusion Rates - a Randomized, Double-Blind Study

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.

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
worst pain	first postoperative day

Secondary Outcome Measures

Outcome Measure	Time Frame
Average pain	1st, 2nd and 3rd postoperative days
Opioid consumption	first, second and third postoperative days
Side effects	1st, 2nd and 3rd postoperative days

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Investigators: Principal Investigator: Dusanka Zaric, MD pHd, Ndr. Fasanvej 57 2000 Frederiksberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): January 25, 2008

Study Record Updates

• Last Update Posted (Estimate): January 29, 2009
• Last Update Submitted That Met QC Criteria: January 28, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Postoperative pain treatment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: EudraCT2007-005180-10; 9445-DZ