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 Enhanc

• Status: Completed
• Trial end date: 2020-11-24
• Target enrollment: 0
• Participant gender: All

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 cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC).

A 4Q-TAP block is also known as an abdominal wall block and TEA is also known as a thoracic epidural. Both are types of anesthetics but are given in different ways. A 4Q-TAP block is when anesthetic injections are given in 4 different parts of the abdomen. A TEA is when an anesthetic injection is given in the space surrounding the spinal cord through your back.

This is an investigational study. The surgery and the levels of anesthetic participant is receiving are standard-of-care. It is investigational to compare 4Q-TAP block with TEA.

Up to 140 participants will be enrolled in this study. All will take part at MD Anderson.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Written Informed consent

2. 18 years old or older

3. American Society of Anesthesiologists physical status (ASA) 1-3

4. Scheduled surgery: open elective CRS-HIPEC

5. Able to complete the QoR 15 questionnaire

6. Patients scheduled to receive intraoperative chemotherapy

Exclusion Criteria:

1. Thrombocytopenia (platelet count: <100,000 cell/dL), coagulopathy (International Normalized Ratio > 1.5, PT>16.5 seconds or aPTT > 35.9 seconds)

2. Bupivacaine or liposomal bupivacaine sensitive or known allergy;

3. Pregnancy or breastfeeding patients

4. 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)

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)

6. Chronic opioid use defined as daily opioid use for more than one month prior the scheduled date of surgery