Clinical trial NCT03214510: Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
Official title: Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver and Intrahepatic Bile Duct Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This phase III trial studies how well thoracic epidural analgesia or four-quadrant transversus abdominus plane block works in reducing pain in patients undergoing liver surgery. It is not yet known whether thoracic epidural analgesia or four-quadrant transversus abdominus plane block may help people to recover more completely and more quickly after surgery.

Detailed description: PRIMARY OBJECTIVE:

I. To compare length of hospital stay between patients treated with thoracic epidural analgesia (TEA) versus (vs.) pre-incision ultrasound-guided, four-quadrant transversus abdominus plane (TAP) block after open liver resection within an enhanced recovery program.

SECONDARY OBJECTIVES:

I. To compare the area under the curve of early (0-48 hour) post-operative pain scores and number of patients who experience severe postoperative pain between the TEA and TAP groups.

II. To compare anesthetic-related complication rates and need to change modalities between TEA and TAP groups.

III. To compare surgery-related complications (including 30-day readmission and 90-day mortality rates) between TEA and TAP groups.

IV. To compare return to baseline symptom burden, functional and cognitive status between TEA and TAP groups.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.

ARM II: Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing open liver resection without bowel resection/anastomosis for malignancy at MD Anderson Cancer Center
* Patients must sign a study-specific consent form
* Platelets \>= 100,000/ml (within 30 days of surgery)
* International normalized ratio (INR) =\< 1.5 (within 30 days of surgery)
* Activated partial thromboplastin time (aPTT) =\< 40 (within 30 days of surgery)
* Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement

Exclusion Criteria:

* Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
* History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
* Anaphylaxis to local anesthetics or narcotics
* Previous or current neurologic disease affecting the lower hemithorax or below
* Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia
* Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion
* Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
* Known bleeding diathesis or coagulopathy
* Psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions)
* Inability to comply with study and/or follow-up procedures
* Patient refusal to participate in randomization
* Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
* Patients with obvious unresectable disease prior to signing informed consent
* Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior abdominal wall reconstruction

Primary outcomes:
measure: Total length of inpatient stay
timeFrame: Up to 5 years
Secondary outcomes:
measure: Early post-operative pain control
timeFrame: Within 48 hours post surgery
measure: Complication rates secondary to the analgesic regimen
timeFrame: Up to 5 years
measure: Surgical complication rates
timeFrame: Up to 5 years
measure: Measures of functional recovery
timeFrame: Up to 5 years
Other outcomes:
measure: Time to readiness for RIOT (return to intended oncologic therapy)
timeFrame: Up to 5 years
measure: Narcotic utilization
timeFrame: Up to 5 years
measure: Compliance with ordering and delivery of Enhanced Recovery After Surgery program elements
timeFrame: Up to 5 years
measure: Cost of perioperative care
timeFrame: Up to 5 years
measure: Biologic inflammatory markers
timeFrame: Up to 5 years
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Timothy E. Newhook, MD
role: PRINCIPAL_INVESTIGATOR
References: