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
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|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Lidocaine
0.5% lidocaine infusion hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
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.
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
- Resting Visual Analogue Scale average in the first 24 hours [ Time Frame: 1 day ]Visual analogue scale
- Patient satisfaction [ Time Frame: 7 days ]five point likert
- Problems patient using the pump [ Time Frame: 7 days ]Survey of local anesthetic toxicity, patient falls, catheter and exits pump problems,
- Worse daily Visual Analogue Scale [ Time Frame: 7 days ]Visual analogue scale
- Number of patients using rescue analgesia and number of doses per patient [ Time Frame: 7 days ]Milligrams of tramadol used
- 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
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
|División de Anestesia - Facultad de Medicina Pontificia Universidad Católica|
|Santiago, Región Metropolitana, Chile, 8330024|
|Principal Investigator:||Fernando R Altermatt, MD||Assistant Professor|