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

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300377
• Other study ID #: 008-197
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 26, 2018

Study information

• Verified date: January 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 26, 2018
• Est. primary completion date: December 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• 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.
• Lidocaine
10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.

Locations

Country	Name	City	State
United States	Baylor Jack and Jane Heart and Vascular Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 Years
Secondary	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.	3 Years