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

NCT01300377 | Completed

• 1 other identifier: 008-197
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Keywords

Post-operative pain; pain; pacemaker; defibrillator; post-operative narcotic use; local anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Post-Operative Narcotic Use

  3 Years

Study Arms (2)

Bupivacaine / Lidocaine

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.

Drug: Bupivacaine / Lidocaine

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

Interventions

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.

Bupivacaine / Lidocaine

Lidocaine DRUG

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

Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arrythmia patients receiving pacemaker or cardiac defibrillator devices at Baylor Heart and Vascular Institute.

You may not qualify if:

• Receiving complicated procedures
• Replacement of parts, not inclusive of leads

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Jack and Jane Heart and Vascular Institute

Dallas, Texas, 75226, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: November 1, 2008
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: July 10, 2019

Record last verified: 2018-01

Locations

US (1)