Study of Exparel Versus Epidural for Pain Control After Thoracotomy

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Pain Following Thoracotomy Surgery

Treatments: Drug: Epidural; Drug: Intercostal Bupivicaine (Exparel)

Study type: Interventional

Funder types: Other

Identifiers

NCT02178553

14-002940

Details and patient eligibility

About

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

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

Epidural

Active Comparator group

Description:

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.

Treatment:

Drug: Epidural

Intercostal bupivicaine (Exparel)

Active Comparator group

Description:

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.

Treatment:

Drug: Intercostal Bupivicaine (Exparel)