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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

A DOUBLE-BLIND RANDOMIZED TRIAL ASSESSING THE ASSOCIATION BETWEEN TYPE OF LOCAL ANESTHESIA TREATMENT AND POSTOPERATIVE PAIN IN PATIENTS IN HAVING UNDERGONE ARRHYTHMIA SURGERY

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01300377
Enrollment
350
Registered
2011-02-21
Start date
2008-11-01
Completion date
2018-12-26
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Keywords

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

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.

Interventions

DRUGBupivacaine / 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.

DRUGLidocaine

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

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients With Post-Operative Narcotic Use1 dayComparing the patients that received post operative morphine (or equivalents) in the Bupivacaine/Lidocaine versus the Lidocaine alone.

Countries

United States

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
127 Participants
Age, Categorical
Between 18 and 65 years
94 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
168 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
27 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
294 Participants
Region of Enrollment
United States
350 participants
Sex: Female, Male
Female
128 Participants
Sex: Female, Male
Male
112 Participants
Type of Surgery: ICD173 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1770 / 173
other
Total, other adverse events
0 / 1770 / 173
serious
Total, serious adverse events
0 / 1770 / 173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026