Phase 3
Completed N=161
Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
Source: ClinicalTrials.gov NCT01438476 ↗Enrolled (actual)
161
Serious AEs
17.1%
Results posted
Feb 2020
Primary outcomePrimary: Postoperative Pain Experience — 78.6; 105.2 score on a scale* hour
◆ Published Evidence
Established
87citations · ~10 / year
A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery.
Summary
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.
Linked Publications (2)
-
A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery.
-
Inflammation and pro-resolution inflammation after hepatobiliary surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Experience |
78.6; 105.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD Anderson Cancer Center.
- Patients 18 years of age and older. There will be no upper age restriction.
- Patients must sign a study-specific consent form.
- Adequate coagulation function within 30 days of surgery: Platelets >/= 100,000/ml; international normalized ratio (INR) </= 1.5; activated partial thromboplastin time (aPTT) </= 40.
- 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 or pancreatic surgery.
- History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively.
- 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, except for total intravenous anesthesia (TIVA).
- Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion.
- Ongoing use or planned peri-operative use of anticoagulants (not including deep vein thrombosis (DVT) prophylaxis).
- Known bleeding diathesis or coagulopathy.
- 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).
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01438476) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.