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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Lidocaine | Active Comparator | Lidocaine - 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Jack and Jane Heart and Vascular Institute | Dallas | Texas | 75226 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2024 | |
| Reset | Jun 12, 2024 | |
| Release | Oct 12, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2012 | Jan 16, 2018 |
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| Lidocaine | Drug | 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only. |
|
| 3 Years |
| Reset | Oct 24, 2025 |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2014 | Jan 16, 2018 | Prot_SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2024 | Jun 12, 2024 | |||
| Oct 12, 2025 | Oct 24, 2025 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
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