Status:
COMPLETED
Four Quadrants Transverse Abdominus Plane (4Q-TAP) Block With Plain and Liposomal Bupivacaine vs. Thoracic Epidermal Analgesia (TEA) in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) on an Enhanced Recovery Pathway
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Peritoneal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical research study is to compare the effects of 4 quadrant TAP block (4Q-TAP block) with the standard-of-care thoracic epidural analgesia (TEA) in patients recovering from cytore...
Detailed Description
Baseline Tests: If participant agrees to take part in this study, within 60 days before participant's surgery: * Participant will have a physical exam. * Blood (about 8 teaspoons) will be drawn for ...
Eligibility Criteria
Inclusion
- Written Informed consent
- 18 years old or older
- American Society of Anesthesiologists physical status (ASA) 1-3
- Scheduled surgery: open elective CRS-HIPEC
- Able to complete the QoR 15 questionnaire
- Patients scheduled to receive intraoperative chemotherapy
Exclusion
- Thrombocytopenia (platelet count: \<100,000 cell/dL), coagulopathy (International Normalized Ratio \> 1.5, PT\>16.5 seconds or aPTT \> 35.9 seconds)
- Bupivacaine or liposomal bupivacaine sensitive or known allergy;
- Pregnancy or breastfeeding patients
- Patients with recent (within 60 days preoperatively) history severe hepatic disease (defined as liver injury with encephalopathy plus impaired synthetic liver function (i.e. \>1.5)
- Patients with recent (within 15 days preoperatively) history deteriorate kidney function (creatinine serum concentrations \> 2.5 mg/dL or eGFR \< 30 mL/kg/min)
- Chronic opioid use defined as daily opioid use for more than one month prior the scheduled date of surgery
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03359811
Start Date
November 27 2017
End Date
November 24 2020
Last Update
February 18 2022
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030