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Hallux ValgusPhase 4NCT02121119

Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

A Phase 4 study testing Lidocaine and Bupivacaine in people with Hallux Valgus, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Hallux Valgus
What is being tested?
Lidocaine and Bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteChile
Study dates
Sep 2013to Sep 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

    Santiago, Santiago Metropolitan, 8330024

Other trials in Chile

About this study

Official title: Sciatic Popliteal Nerve Block in Foot Surgery: Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

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.

Read more

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 .

Conditions
Hallux Valgus
Being tested
Lidocaine, Bupivacaine
Keywords
Peripheral nerve block, Lidocaine, Bupivacaine
Medical subject headings
Hallux Valgus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

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

  • BupivacaineDrug

    Also called Marcaine

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

Study groups in NCT02121119
Study groupRoleWhat they receive
LidocaineActive comparator0.5% lidocaine infusion hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
Receives: Drug: Lidocaine
BupivacainePlacebo comparatorInfusion of 0.1% bupivacaine hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Visual analogue scale

    Measured: 1 day

Secondary outcomes (5)
  1. Patient satisfaction

    five point likert

    Measured: 7 days

  2. Problems patient using the pump

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

    Measured: 7 days

  3. Worse daily Visual Analogue Scale

    Visual analogue scale

    Measured: 7 days

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

    Milligrams of tramadol used

    Measured: 7 days

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

    Visual analogue scale

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2014
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121119
Sponsor's protocol ID
13-289
Status last verified
Sep 2015
First submitted
11 Nov 2013
Last updated
24 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine and Bupivacaine in people with Hallux Valgus, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resting Visual Analogue Scale average in the first 24 hours (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.

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