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CompletedNCT02121119Updated May 24, 2016

Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

A Phase 4 interventional study of Lidocaine and Bupivacaine in Hallux Valgus, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-24.

Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Hallux Valgus

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Keywords

  • Peripheral nerve block
  • Lidocaine
  • Bupivacaine
03

In context

Hallux Valgus

144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.

This study's enrollment of 70 is above the median of 56 across 106 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Chronic pain.
  • Illicit drug use
  • Pregnancy
  • Psychiatric disease
  • Chronic use of analgesia
  • Peripheral neuropathy
  • History of severe Gastroesophageal reflux disease
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Lidocaine

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

    Drug: Lidocaine

  • Placebo comparator
    Bupivacaine

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

    Drug: Bupivacaine

Interventions

  • DrugLidocaine

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

  • DrugBupivacaine

    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

06

What researchers measure

Primary outcomes

  1. Resting Visual Analogue Scale average in the first 24 hours

    Visual analogue scale

    Time frame: 1 day

Secondary outcomes

  1. Patient satisfaction

    five point likert

    Time frame: 7 days

  2. Problems patient using the pump

    Survey of local anesthetic toxicity, patient falls, catheter and exits pump problems,

    Time frame: 7 days

  3. Worse daily Visual Analogue Scale

    Visual analogue scale

    Time frame: 7 days

  4. Number of patients using rescue analgesia and number of doses per patient

    Milligrams of tramadol used

    Time frame: 7 days

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

    Visual analogue scale

    Time frame: 7 days

07

Study locations

1 site
  • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
    Santiago, Región Metropolitana 8330024, Chile
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02121119
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Apr 23, 2014
Start date
Sep 2013
Primary completion
Sep 2014
Completion
Sep 2015
Last update
May 24, 2016

Study contacts

Fernando R Altermatt, MD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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