Clinical trial · Interventional
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
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: A Non-inferiority Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine HCl | Drug | — | UNRESOLVED |
| Liposomal Bupivacaine | Drug | — | UNRESOLVED |
| Local Anesthetic Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard-of-Care Thoracic Epidural Analgesia (TEA)
- description
- An epidural catheter placed before induction of anesthesia by an anesthesiologist. A bolus or infusion of the local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.
- interventionNames
- Drug: Local Anesthetic Solution
- type
- ACTIVE_COMPARATOR
- label
- 4Q-TAP Blocks
- description
- Participants have an ultrasound guided 4Q-TAP block. A maximum of 80 cc of a solution consisting of 30 mg of bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) and 65 mg of liposomal bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
- interventionNames
- Drug: Bupivacaine HCl
- Drug: Liposomal Bupivacaine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available