Status:
COMPLETED
Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Liver Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 liv...
Detailed Description
Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. For every participant assigned to Group 1, 3 participants will be ass...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2017
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01438476
Start Date
January 26 2012
End Date
October 18 2017
Last Update
February 12 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030