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Completed

NCT Number: NCT01300377

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

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Jack and Jane Heart and Vascular Institute

Dallas, Texas, 75226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine / Lidocaine

Drug

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

Drug

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

Primary outcomes

  1. Pain Scores on the Visual Analog Scale

    Time frame: 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 outcomes

  1. Total Post-Operative Narcotic Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Feb 21, 2011
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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