Comparing pain relief methods for liver surgery patients
Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
This study tests which pain relief method works better for people having liver surgery, comparing a spinal block to a different type of pain control to see which helps them recover faster and stay in the hospital for a shorter time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03214510 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness of thoracic epidural analgesia versus four-quadrant transversus abdominus plane block in reducing pain for patients undergoing open liver resection. Patients are randomly assigned to receive either thoracic epidural analgesia or a TAP block before surgery, with the primary goal of comparing hospital stay lengths. Secondary objectives include assessing postoperative pain scores, complication rates, and recovery outcomes between the two methods.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for open liver resection without bowel resection for malignancy at MD Anderson Cancer Center.
Not a fit: Patients with severe uncontrolled systemic diseases or chronic narcotic use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and faster recovery for patients undergoing liver surgery.
How similar studies have performed: Previous studies have shown varying success with similar analgesic techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Timothy E. Newhook, MD — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.