Clinical trial · Interventional
Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery. The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Patient-Controlled Analgesia (IVPCA) | Procedure | — | UNRESOLVED |
| Pain Assessment | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Thoracic Epidural Analgesia (TEA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IV Pain Management
- description
- Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
- interventionNames
- Procedure: Intravenous Patient-Controlled Analgesia (IVPCA)
- Behavioral: Questionnaires
- Behavioral: Pain Assessment
- type
- EXPERIMENTAL
- label
- Epidural Pain Management
- description
- Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
- interventionNames
- Procedure: Thoracic Epidural Analgesia (TEA)
- Behavioral: Questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD Anderson Cancer Center. 2. Patients 18 years of age and older. There will be no upper age restriction. 3. Patients must sign a study-specific consent form. 4. Adequate coagulation function within 30 days of surgery: Platelets \>/= 100,000/ml; international normalized ratio (INR) \</= 1.5; activated partial thromboplastin time (aPTT) \</= 40. 5. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement. Exclusion Criteria: 1. Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery. 2. History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively. 3. Anaphylaxis to local anesthetics or narcotics. 4. Previous or current neurologic disease affecting the lower hemithorax or below. 5. Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for total intravenous anesthesia (TIVA). 6. Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion. 7. Ongoing use or planned peri-operative use of anticoagulants (not including deep vein thrombosis (DVT) prophylaxis). 8. Known bleeding diathesis or coagulopathy. 9. Educational, 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). 10. Inability to comply with study and/or follow-up procedures. 11. Patient refusal to participate in randomization. 12. Pregnant women are excluded from this study; women of childbearing potential (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. 13. Patients with obvious unresectable disease prior to signing informed consent.
References
Publications (2)
- DERIVEDCata JP, Velasquez JF, Ramirez MF, Vauthey JN, Gottumukkala V, Conrad C, Kim BJ, Aloia T. Inflammation and pro-resolution inflammation after hepatobiliary surgery. World J Surg Oncol. 2017 Aug 10;15(1):152. doi: 10.1186/s12957-017-1220-6. PMID 28807031
- DERIVEDAloia TA, Kim BJ, Segraves-Chun YS, Cata JP, Truty MJ, Shi Q, Holmes A, Soliz JM, Popat KU, Rahlfs TF, Lee JE, Wang XS, Morris JS, Gottumukkala VNR, Vauthey JN. A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery. Ann Surg. 2017 Sep;266(3):545-554. doi: 10.1097/SLA.0000000000002386. PMID 28746153