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Completed

NCT Number: NCT02197988

TAP Versus Thoracic Epidural in Major Abdominal Resections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel 1.33% (20ml Volume)

Drug

Transversus Abdominis Plane Block

Other names: TAP Block, Transversus Abdominis Plane Block

0.125% bupivicaine with 2 mcg/ml Fentanyl.

Drug

Thoracic Epidural Anesthesia

Other names: Epidural, Thoracic Epidural Anesthesia

Primary outcomes

  1. Hypotension

    Time frame: First 24-72 hours postoperatively

    The incidence of systolic blood pressure less than 90 mmHg and fluid requirements

Secondary outcomes

  1. Patient satisfaction relative to pain control and amount of additional narcotic usage

    Time frame: Post operative day two during hospitalization

    A short patient survey during the postoperative period which will collect information on pain management.

Other outcomes

  1. Cost Evaluation

    Time frame: Postoperative hospitalization an expected average of 6 months

    Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2014
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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