A Phase 3 interventional study of Bupivacaine and Fentanyl in Liver and Intrahepatic Bile Duct Disorder, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Supportive care
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.
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.
613 studies on the registry are indexed under Digestive System Diseases; 118 are open to participants now.
This study's enrollment of 101 is above the median of 80 across 401 interventional studies indexed under Digestive System Diseases.
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Exclusion Criteria:
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.
Drug: Bupivacaine · Drug: Fentanyl · Drug: Hydromorphone Hydrochloride · Device: Implanted Medical Device · Behavioral: Questionnaire
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
Drug: Bupivacaine · Device: Implanted Medical Device · Drug: Liposomal Bupivacaine · Behavioral: Questionnaire
Given via thoracic epidural catheter or TAP block
Also known as: AH 250
Given via thoracic epidural catheter
Also known as: Abstral, Duragesic
Given via thoracic epidural catheter
Also known as: Dilaudid, Dilaudid HP, Dimorphone, Exalgo, Hydromorphone, Hydrostat, Hymorphan, Laudicon, Novolauden
Undergo placement of thoracic epidural catheter
Also known as: IMPLANTED
Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
Also known as: IMPLANTED
Given via TAP block
Also known as: Bupivacaine Liposome Injectable Suspension, Exparel
Ancillary studies
Also known as: Questionnaires
Total length of inpatient stay
Will be recorded and compared between groups. Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
Time frame: Up to 5 years
Early post-operative pain control
The area under the curve for each patient will be computed using the trapezoidal method using the pain score by time curve as has been done in prior studies of this type at MD Anderson. Will be compared between groups. In addition, the number of patients experiencing severe pain (\>= 7/10) during the inpatient recovery period will be compared between study groups. Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
Time frame: Within 48 hours post surgery
Complication rates secondary to the analgesic regimen
Pain control modality complications will be prospectively recorded including epidural hematoma, epidural catheter migration/malfunction, injection/exit site cellulitis, epidural abscess, cerebrospinal fluid leak, prolonged ileus (defined as inability to tolerate regular diet by post operation day 5), imbalance and gait instability, altered mental status and delirium, and need to change pain control modality due to inadequate pain control. The rate of these complications will be compared between study groups. Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Time frame: Up to 5 years
Surgical complication rates
Postoperative surgical complications will be prospectively recorded and graded using the Accordian grading scale. Liver surgery specific complications including bile fistula, bleeding requiring transfusion and liver failure will be recorded. 30-day readmission and 90-day mortality will be recorded. The rates of these complications will be compared between study groups. Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Time frame: Up to 5 years
Measures of functional recovery
Quality of recovery will be assessed using the MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) at regimented intervals including preoperative baseline and postoperative inpatient and outpatient recovery, Return to baseline symptoms including return to baseline life interference summary score at 6 weeks postoperatively, measured using the MDASI-GI, will be compared between groups. Likewise, pre- and post-operative physical and cognitive performance recovery will be compared between groups. Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
Time frame: Up to 5 years
Time to readiness for RIOT (return to intended oncologic therapy)
Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated. To assess the relationship between study variables and time to event outcomes (such as RIOT), Kaplan-Meier plots and log-rank tests will be used.
Time frame: Up to 5 years
Narcotic utilization
Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
Time frame: Up to 5 years
Compliance with ordering and delivery of Enhanced Recovery After Surgery program elements
Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Time frame: Up to 5 years
Cost of perioperative care
Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
Time frame: Up to 5 years
Biologic inflammatory markers
Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
Time frame: Up to 5 years
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center