TAP Versus Thoracic Epidural in Major Abdominal Resections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing major surgery. The two methods being compared are the thoracic epidural and the TAP block. The thoracic epidural method involves medication being given through a patient's back and the TAP block involves medication being given through a patient's abdomen (belly). The investigators will compare side effects experienced by the patients that take part in this study, including a change in blood pressure, as well as the patients' opinions about their pain management experience after surgery.

Detailed Description
-----------------
The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method. This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study. Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care. Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.

Official Title
-----------------
Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial

Conditions
-----------------
Malignant Neoplasm of Abdomen, Surgery

Intervention / Treatment
-----------------
* Drug: Exparel 1.33% (20ml Volume)
* Drug: 0.125% bupivicaine with 2 mcg/ml Fentanyl.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures Patient agrees to participate in this study and provides informed consent Exclusion criteria: Surgical cases combined with thoracic surgeries Surgical cases where the abdominal operation is performed laparoscopically Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations) Adults unable to provide informed consent Children Pregnant women Prisoners Non-English speaking subjects Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Transversus Abdominis Plane Block<br>Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume) | Drug: Exparel 1.33% (20ml Volume)<br>* Transversus Abdominis Plane Block<br>* Other names: Transversus Abdominis Plane Block;|
| Active Comparator: Thoracic Epidural Anesthesia<br>Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl | Drug: 0.125% bupivicaine with 2 mcg/ml Fentanyl.<br>* Thoracic Epidural Anesthesia<br>* Other names: Thoracic Epidural Anesthesia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | The incidence of systolic blood pressure less than 90 mmHg and fluid requirements | First 24-72 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction relative to pain control and amount of additional narcotic usage | A short patient survey during the postoperative period which will collect information on pain management. | Post operative day two during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Abdominal, Epidural Anesthesia, Transversus Abdominis Plane Block, TAP block