Study of Exparel Versus Epidural for Pain Control After Thoracotomy

Study Overview
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Brief Summary
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Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.

Detailed Description
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In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.

Official Title
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Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy

Conditions
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Pain Following Thoracotomy Surgery

Intervention / Treatment
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* Drug: Epidural
* Drug: Intercostal Bupivicaine (Exparel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy). Exclusion Criteria: Planned chest wall resection or abdominal incision and/or gastroesophageal surgery; Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution); Daily opioid therapy; Current gabapentin or pregabalin therapy; Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement; Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals; Severe hepatic, renal or cardiovascular disorders. Women who are pregnant will not be included in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural<br>In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr. | Drug: Epidural<br> <br> |
| Active Comparator: Intercostal bupivicaine (Exparel)<br>In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered. | Drug: Intercostal Bupivicaine (Exparel)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores With Cough on First Postoperative Day | Pain with cough documented using the numerical rating scale pain scores (0-10) | In the morning (8 am) on first postoperative day | 
| Pain Scores With Cough on the Second Postoperative Day | Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine. | In the morning (8 am) on the second postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores at Rest in the Morning on the First Postoperative Day | NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine. | Each morning for two days postoperative | 
| Pain Scores at Rest on the Second Postoperative Day | NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine. | Each morning for two days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracotomy, Pain