Study of Exparel Versus Epidural for Pain Control After Thoracotomy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-002940
NCT ID: NCT02178553
Sponsor Protocol Number: 14-002940
About this study
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 SMH are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intraoperatively can provide comparable pain relief.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator James Hannon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available