A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery

Not Applicable

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Bupivacaine / Lidocaine; Drug: Lidocaine

• Registration Number: NCT01300377
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Status Verified: 2018-01
• Primary Completion: 2018-12-26
• Study Completion: 2018-12-26
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine / Lidocaine	Bupivacaine / Lidocaine	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	Lidocaine	Lidocaine - 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.

Primary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale	3 Years	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

Name	Time	Method
Total Post-Operative Narcotic Use	3 Years	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.

Trial Locations

Locations (1)

Baylor Jack and Jane Heart and Vascular Institute; 🇺🇸 Dallas, Texas, United States