Liver and Intrahepatic Bile Duct DisorderPhase 3NCT03214510
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
A Phase 3 study testing Bupivacaine, Fentanyl and Hydromorphone Hydrochloride in people with Liver and Intrahepatic Bile Duct Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver and Intrahepatic Bile Duct Disorder
- What is being tested?
- Bupivacaine, Fentanyl and Hydromorphone Hydrochloride
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2017to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Bupivacaine, Fentanyl, Hydromorphone Hydrochloride, Implanted Medical Device, Liposomal Bupivacaine
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called AH 250
Given via thoracic epidural catheter or TAP block
FentanylDrug
Also called Abstral, Duragesic
Given via thoracic epidural catheter
Hydromorphone HydrochlorideDrug
Also called Dilaudid, Dilaudid HP, Dimorphone, Exalgo
Given via thoracic epidural catheter
Implanted Medical DeviceDevice
Also called IMPLANTED
Undergo placement of thoracic epidural catheter
Implanted Medical DeviceDevice
Also called IMPLANTED
Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
Liposomal BupivacaineDrug
Also called Bupivacaine Liposome Injectable Suspension, Exparel
Given via TAP block
QuestionnaireBehavioural
Also called Questionnaires
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (TAE) | Experimental | 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. Receives: Drug: Bupivacaine; Drug: Fentanyl; Drug: Hydromorphone Hydrochloride; Device: Implanted Medical Device; Behavioral: Questionnaire |
| Arm II (TAP) | Experimental | Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block. Receives: Drug: Bupivacaine; Device: Implanted Medical Device; Drug: Liposomal Bupivacaine; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start4 Oct 2017
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Intrahepatic Bile Duct DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy E. Newhook, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214510
- Sponsor's protocol ID
- 2016-1111
- Other IDs
- NCI-2018-01124, 2016-1111
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2017
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
- ClinicalTrials.gov ID
- NCT03214510
- Acronym / sponsor ID
- 2016-1111
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (TAE) | Experimental | Drug: Bupivacaine, Drug: Fentanyl, Drug: Hydromorphone Hydrochloride, Device: Implanted Medical Device, Behavioral: QuestionnairePatients 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 (TAP) | Experimental | Drug: Bupivacaine, Device: Implanted Medical Device, Drug: Liposomal Bupivacaine, Behavioral: QuestionnairePatients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: AH 250Given via thoracic epidural catheter or TAP block | Drug | Arm I (TAE), Arm II (TAP) |
| FentanylAlso: Abstral, DuragesicGiven via thoracic epidural catheter | Drug | Arm I (TAE) |
| Hydromorphone HydrochlorideAlso: Dilaudid, Dilaudid HP, Dimorphone, ExalgoGiven via thoracic epidural catheter | Drug | Arm I (TAE) |
| Implanted Medical DeviceAlso: IMPLANTEDUndergo placement of thoracic epidural catheter | Device | Arm I (TAE) |
| Implanted Medical DeviceAlso: IMPLANTEDUndergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block | Device | Arm II (TAP) |
| Liposomal BupivacaineAlso: Bupivacaine Liposome Injectable Suspension, ExparelGiven via TAP block | Drug | Arm II (TAP) |
| QuestionnaireAlso: QuestionnairesAncillary studies | Behavioural | Arm I (TAE), Arm II (TAP) |
Primary outcome
Total length of inpatient stay
Time frame: Up to 5 years
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.
4 secondary outcomes
Early post-operative pain control
Time frame: Within 48 hours post surgery
Complication rates secondary to the analgesic regimen
Time frame: Up to 5 years
Surgical complication rates
Time frame: Up to 5 years
Measures of functional recovery
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy E. Newhook, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine, Fentanyl and Hydromorphone Hydrochloride in people with Liver and Intrahepatic Bile Duct Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of inpatient stay (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.