A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine / Lidocaine
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Post-operative pain, pain, pacemaker, defibrillator, post-operative narcotic use, local anesthesia
Eligibility Criteria
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
Sites / Locations
- Baylor Jack and Jane Heart and Vascular Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bupivacaine / Lidocaine
Lidocaine
Arm Description
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.
Lidocaine - 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Outcomes
Primary Outcome Measures
Pain Scores on the Visual Analog Scale
To assess the association between standard local anesthetic choice (Lidocaine or a combination of Marcaine and Lidocaine) and postoperative pain in patients receiving a pacemaker or defibrillator. Pain will be measured using the visual analog scale (a standardized and validated scale) at 3 time points: prior to surgery, once awakened from surgery, and 4 hours after.
Secondary Outcome Measures
Total Post-Operative Narcotic Use
To assess the association between local anesthetic choice (Lidocaine or a combination of Marcaine and Lidocaine) and narcotic use (including dosages and strength of narcotic) within 4 hours after the patient emerges from general anesthesia. The type, number, and dose of narcotics will be collected up to 4 hours after patient awakens from surgery. Narcotics administered will be standardized to the equivalent dose of morphine.
Full Information
NCT ID
NCT01300377
First Posted
February 18, 2011
Last Updated
July 8, 2019
Sponsor
Baylor Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01300377
Brief Title
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 26, 2018 (Actual)
Study Completion Date
December 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Post-operative pain, pain, pacemaker, defibrillator, post-operative narcotic use, local anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine / Lidocaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine - 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine / Lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
To assess the association between standard local anesthetic choice (Lidocaine or a combination of Marcaine and Lidocaine) and postoperative pain in patients receiving a pacemaker or defibrillator. Pain will be measured using the visual analog scale (a standardized and validated scale) at 3 time points: prior to surgery, once awakened from surgery, and 4 hours after.
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Total Post-Operative Narcotic Use
Description
To assess the association between local anesthetic choice (Lidocaine or a combination of Marcaine and Lidocaine) and narcotic use (including dosages and strength of narcotic) within 4 hours after the patient emerges from general anesthesia. The type, number, and dose of narcotics will be collected up to 4 hours after patient awakens from surgery. Narcotics administered will be standardized to the equivalent dose of morphine.
Time Frame
3 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Baylor Jack and Jane Heart and Vascular Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
12. IPD Sharing Statement
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A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
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