Post-operative Pain
Conditions
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
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.
10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Post-Operative Narcotic Use | 1 day | Comparing 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: ICD | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 177 | 0 / 173 |
| other Total, other adverse events | 0 / 177 | 0 / 173 |
| serious Total, serious adverse events | 0 / 177 | 0 / 173 |