TAP Versus Thoracic Epidural in Major Abdominal Resections

NCT ID: NCT02197988

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-03
• Study Completion Date: 2016-08-31

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.

Conditions

Malignant Neoplasm of Abdomen; Surgery

Study Design

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

Study Groups

Transversus Abdominis Plane Block

Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)

Group Type: ACTIVE_COMPARATOR

Exparel 1.33% (20ml Volume)

Intervention Type: DRUG

Transversus Abdominis Plane Block

Thoracic Epidural Anesthesia

Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl

Group Type: ACTIVE_COMPARATOR

0.125% bupivicaine with 2 mcg/ml Fentanyl.

Intervention Type: DRUG

Thoracic Epidural Anesthesia

Interventions

Exparel 1.33% (20ml Volume)

Transversus Abdominis Plane Block

Intervention Type: DRUG

0.125% bupivicaine with 2 mcg/ml Fentanyl.

Thoracic Epidural Anesthesia

Intervention Type: DRUG

Other Intervention Names

TAP Block; Transversus Abdominis Plane Block; Epidural; Thoracic Epidural Anesthesia

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

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

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathew Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

Spectrum Health

Grand Rapids, Michigan, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.

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Reference Type: BACKGROUND

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Other Identifiers

2013-218

Identifier Type: -

Identifier Source: org_study_id