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Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

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ClinicalTrials.gov Identifier: NCT02121119
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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.


Condition or disease Intervention/treatment Phase
Hallux Valgus Drug: Lidocaine Drug: Bupivacaine Phase 4

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sciatic Popliteal Nerve Block in Foot Surgery: Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
0.5% lidocaine infusion hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
Drug: Lidocaine
Continuous block with lidocaine in both legs. Lidocaine infusion starts 0.5% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr

Placebo Comparator: Bupivacaine
Infusion of 0.1% bupivacaine hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
Drug: Bupivacaine
Continuous block with lidocaine in both legs. Infusion starts bupivacaine 0.1% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr
Other Name: Marcaine




Primary Outcome Measures :
  1. Resting Visual Analogue Scale average in the first 24 hours [ Time Frame: 1 day ]
    Visual analogue scale


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 7 days ]
    five point likert

  2. Problems patient using the pump [ Time Frame: 7 days ]
    Survey of local anesthetic toxicity, patient falls, catheter and exits pump problems,

  3. Worse daily Visual Analogue Scale [ Time Frame: 7 days ]
    Visual analogue scale

  4. Number of patients using rescue analgesia and number of doses per patient [ Time Frame: 7 days ]
    Milligrams of tramadol used

  5. Resting and dynamic Visual Analogue Scale average in Post anesthesia care unit, 48, 72 hours and 7 days [ Time Frame: 7 days ]
    Visual analogue scale



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121119


Locations
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Chile
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Región Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Fernando R Altermatt, MD Assistant Professor

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02121119     History of Changes
Other Study ID Numbers: 13-289
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Pontificia Universidad Catolica de Chile:
Peripheral nerve block
Lidocaine
Bupivacaine
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action