Overview

This trial is active, not recruiting.

Condition post-operative pain
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Lidocaine/Bupivacaine mixture - 5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
bupivacaine / lidocaine
5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
(Active Comparator)
Lidocaine - 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
lidocaine
10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.

Primary Outcomes

Measure
Pain Scores on the Visual Analog Scale
time frame: 3 Years

Secondary Outcomes

Measure
Total Post-Operative Narcotic Use
time frame: 3 Years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Baylor Research Institute.