Study of Exparel Versus Epidural for Pain Control After Thoracotomy

NCT ID: NCT02178553

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-15
• Study Completion Date: 2019-01-25

Brief Summary

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

Detailed 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.

Conditions

Pain Following Thoracotomy Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epidural

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.

Group Type: ACTIVE_COMPARATOR

Epidural

Intervention Type: DRUG

Intercostal bupivicaine (Exparel)

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.

Group Type: ACTIVE_COMPARATOR

Intercostal Bupivicaine (Exparel)

Intervention Type: DRUG

Interventions

Epidural

Intervention Type: DRUG

Intercostal Bupivicaine (Exparel)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

James D. Hannon, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James D Hannon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-002940

Identifier Type: -

Identifier Source: org_study_id