Pain relief showdown: which method helps liver surgery patients recover faster?
NCT ID NCT03214510
First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This phase III trial compares two pain relief methods for patients undergoing open liver surgery for cancer: thoracic epidural analgesia and a four-quadrant TAP block. The study aims to see which method leads to a shorter hospital stay and better pain control. About 101 participants are being studied at MD Anderson Cancer Center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bupivacaine, Fentanyl, Hydromorphone Hydrochloride
- What this could lead to
- If this trial succeeds, it could show that one pain relief method is better for recovery after liver surgery, potentially leading to shorter hospital stays and less pain.
- What could go wrong
- This is a single-center trial with only 101 participants, so results may not apply to all patients. Both methods have known risks like infection or side effects from pain medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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101 people
The number who actually took part.
- Started
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Oct 2017
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.