Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

NCT02121119 | Completed Phase 4 DMC

• 1 other identifier: 13-289
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In practice ambulatory orthopedic surgery, one of the problems of most difficult solution is adequate control of postoperative analgesia. Pain is a frequent cause of consultation and unscheduled readmissions in this group of patients. The use of continuous peripheral nerve blocks are an effective tool in postoperative analgesia. In this connection, most of the studies of continuous infusions of local anesthetics by perineural catheters have been made with bupivacaine, levobupivacaine, and ropivacaine However, it has been found that lidocaine action lasts less, has lower cost and is less toxic than longer-acting agents. The investigators aim is to compare the effectiveness of lidocaine versus bupivacaine continuous popliteal sciatic blockade ambulatory elastomeric pump.

Conditions

Hallux Valgus

Keywords

Peripheral nerve block; Lidocaine; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Resting Visual Analogue Scale average in the first 24 hours

  Visual analogue scale

  1 day

Secondary Outcomes (5)

• Patient satisfaction

  7 days

• Problems patient using the pump

  7 days

• Worse daily Visual Analogue Scale

  7 days

• Number of patients using rescue analgesia and number of doses per patient

  7 days

• Resting and dynamic Visual Analogue Scale average in Post anesthesia care unit, 48, 72 hours and 7 days

  7 days

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

0.5% lidocaine infusion hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.

Drug: Lidocaine

Bupivacaine

PLACEBO COMPARATOR

Infusion of 0.1% bupivacaine hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.

Drug: Bupivacaine

Interventions

Lidocaine DRUG

Continuous block with lidocaine in both legs. Lidocaine infusion starts 0.5% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr

Lidocaine

Bupivacaine DRUG

Continuous block with lidocaine in both legs. Infusion starts bupivacaine 0.1% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr

Also known as: Marcaine

Bupivacaine

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists I or II
• Body mass index between 20 and 34 kg/m2
• Bilateral surgery of ankle or foot.
• Peripheral nerve block and general anesthesia

You may not qualify if:

• Chronic pain.
• Illicit drug use
• Pregnancy
• Psychiatric disease
• Chronic use of analgesia
• Peripheral neuropathy
• History of severe Gastroesophageal reflux disease

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, 8330024, Chile

Location

MeSH Terms

Conditions

Hallux Valgus

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fernando R Altermatt, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: April 23, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2015-09

Locations

CL (1)