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Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Lidocaine
Bupivacaine
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Peripheral nerve block, Lidocaine, Bupivacaine

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Bupivacaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Resting Visual Analogue Scale average in the first 24 hours
Visual analogue scale

Secondary Outcome Measures

Patient satisfaction
five point likert
Problems patient using the pump
Survey of local anesthetic toxicity, patient falls, catheter and exits pump problems,
Worse daily Visual Analogue Scale
Visual analogue scale
Number of patients using rescue analgesia and number of doses per patient
Milligrams of tramadol used
Resting and dynamic Visual Analogue Scale average in Post anesthesia care unit, 48, 72 hours and 7 days
Visual analogue scale

Full Information

First Posted
November 11, 2013
Last Updated
May 22, 2016
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02121119
Brief Title
Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump
Official Title
Sciatic Popliteal Nerve Block in Foot Surgery: Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In the practice of orthopedic outpatient surgery, one of the most intractable problems is proper control of post-operative analgesia . Pain is a frequent cause of consultations and unscheduled readmissions in this group of patients. The use of continuous peripheral nerve blocks are an effective tool in postoperative analgesia , allowing prolong the effect of the blockade by the time you want. Such techniques have been described by different groups for the management of postoperative pain with good results even successfully used in ambulatory practice . However, sending patients home with a continuous infusion pump to local anesthetics causes some problems , such as the method of administration , cost and risk of poisoning by these drugs. With regard to the method of administration , have been used electronic continuous infusion pumps even allow boluses of demand , with good results. However, its use implies a higher cost and are more difficult to use by patients. An alternative of greater simplicity and lower cost is the use of disposable pumps ( elastomeric pumps ) without electronic components , which through a simple mechanism to allow a predetermined continuous infusion flow . It has been seen that the use of elastomeric pumps for continuous peripheral nerve blocks are associated with fewer technical problems and more satisfied patients electronic pumps . Another problem that occurs with the use of ambulatory continuous technical risk is secondary to the administration of local anesthetic solutions long-acting toxicity in a home environment , without immediate medical intervention. While this is a potential risk of toxicity , this problem could be avoided by using less toxic drugs . In this connection , most of the studies of continuous infusion of local anesthetics by perineural catheters have been made with bupivacaine , levobupivacaine , and ropivacaine . However, it has been found that lidocaine lasts less action , has a lower cost and is less toxic than the long-acting agents , although no studies which continuous infusion of lidocaine home . In addition , there is evidence of comparable effectiveness between solutions of bupivacaine and lidocaine in continuous epidural infusion for postoperative analgesia , why lidocaine is likely to be a good alternative for continuous ambulatory blocks . Therefore, the investigators objective is to compare the effectiveness of lidocaine versus bupivacaine in ambulatory popliteal sciatic blockade with continuous elastomeric pump .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Peripheral nerve block, Lidocaine, Bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
0.5% lidocaine infusion hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
Arm Title
Bupivacaine
Arm Type
Placebo Comparator
Arm Description
Infusion of 0.1% bupivacaine hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Continuous block with lidocaine in both legs. Lidocaine infusion starts 0.5% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Continuous block with lidocaine in both legs. Infusion starts bupivacaine 0.1% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr
Primary Outcome Measure Information:
Title
Resting Visual Analogue Scale average in the first 24 hours
Description
Visual analogue scale
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
five point likert
Time Frame
7 days
Title
Problems patient using the pump
Description
Survey of local anesthetic toxicity, patient falls, catheter and exits pump problems,
Time Frame
7 days
Title
Worse daily Visual Analogue Scale
Description
Visual analogue scale
Time Frame
7 days
Title
Number of patients using rescue analgesia and number of doses per patient
Description
Milligrams of tramadol used
Time Frame
7 days
Title
Resting and dynamic Visual Analogue Scale average in Post anesthesia care unit, 48, 72 hours and 7 days
Description
Visual analogue scale
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Chronic pain. Illicit drug use Pregnancy Psychiatric disease Chronic use of analgesia Peripheral neuropathy History of severe Gastroesophageal reflux disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando R Altermatt, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8330024
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

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