TAP Versus Thoracic Epidural in Major Abdominal Resections

Spectrum Health Hospitals

Status

Completed

Conditions

Surgery

Malignant Neoplasm of Abdomen

Treatments

Drug: Exparel 1.33% (20ml Volume)

Drug: 0.125% bupivicaine with 2 mcg/ml Fentanyl.

Study type

Interventional

Funder types

Other

Identifiers

NCT02197988

2013-218

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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