Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121119
• Other study ID #: 13-289
• Status: Completed
• Phase: Phase 4
• First received: November 11, 2013
• Last updated: May 22, 2016
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical 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.

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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

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
• 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

Locations

Country	Name	City	State
Chile	División de Anestesia - Facultad de Medicina Pontificia Universidad Católica	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Visual Analogue Scale average in the first 24 hours	Visual analogue scale	1 day	Yes
Secondary	Patient satisfaction	five point likert	7 days	Yes
Secondary	Problems patient using the pump	Survey of local anesthetic toxicity, patient falls, catheter and exits pump problems,	7 days	Yes
Secondary	Worse daily Visual Analogue Scale	Visual analogue scale	7 days	Yes
Secondary	Number of patients using rescue analgesia and number of doses per patient	Milligrams of tramadol used	7 days	Yes
Secondary	Resting and dynamic Visual Analogue Scale average in Post anesthesia care unit, 48, 72 hours and 7 days	Visual analogue scale	7 days	Yes