A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
This trial is active, not recruiting.
|Treatments||bupivacaine / lidocaine, lidocaine|
|Sponsor||Baylor Research Institute|
|Start date||November 2008|
|End date||December 2016|
|Trial size||300 participants|
|Trial identifier||NCT01300377, 008-197|
The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or defibrillator insertion in subjects who undergo arrhythmia surgery at Baylor Heart and Vascular Institute while adjusting for pertinent clinical and/or demographic factors. No control group is necessary.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (caregiver, investigator)|
Pain Scores on the Visual Analog Scale
time frame: 3 Years
Total Post-Operative Narcotic Use
time frame: 3 Years
Male or female participants at least 18 years old.
Inclusion Criteria: - Arrythmia patients receiving pacemaker or cardiac defibrillator devices at Baylor Heart and Vascular Institute. Exclusion Criteria: - Receiving complicated procedures - Replacement of parts, not inclusive of leads
|Official title||A DOUBLE-BLIND RANDOMIZED TRIAL ASSESSING THE ASSOCIATION BETWEEN TYPE OF LOCAL ANESTHESIA TREATMENT AND POSTOPERATIVE PAIN IN PATIENTS IN HAVING UNDERGONE ARRHYTHMIA SURGERY|
|Description||Patients receiving a pacemaker or defibrillator are currently given Bupivacaine, Lidocaine, or a mixture of the two for local anesthetic treatment (in addition to general anesthesia). The choice of local anesthetic to be used during surgery is based primarily on the differences in time for the anesthetic to take effect and duration thereafter. Lidocaine typically works in less than 1 minute and lasts approximately 45 minutes. Bupivacaine works within 2 to 3 minutes and lasts 4 to 6 hours. Lidocaine is often preferable due to its shorter time of effectiveness. However, its relatively short duration may translate into a higher use of narcotics for pain management during postoperative care - particularly within the first hour following emergence from general anesthesia. Therefore it is conceivable that these patients would have higher levels of pain, higher cost of care related to cost of narcotics, and higher cost of caregiver time required to administer them.|
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