Phase 3
Completed N=70
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
Peritoneal Cancer
Source: ClinicalTrials.gov NCT03359811 ↗
Enrolled (actual)
70
Serious AEs
1.5%
Results posted
Feb 2022
Primary outcomePrimary: Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2 — -45; -50 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2 |
-45; -50 | — |
| SECONDARY 4Q-TAP Versus TEA on Postoperative Pain |
3; 4; 5; 5 | — |
| SECONDARY Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA |
4.5; 21 | — |
| SECONDARY Comparison of the Length of Stay (LOS) Between Patients With 4Q-TAP Versus TEA |
11; 11 | — |
| SECONDARY Number of Participants With Adverse Events Related to 4Q-TAP Versus TEA |
3; 1 | — |
| SECONDARY Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48 |
7; 7 | — |
| SECONDARY Number of Participants With Incidence of Postoperative Complications and Morbidity in Patients Receiving 4Q-TAP Versus TEA |
5; 8; 5; 5; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Thrombocytopenia (platelet count: 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
Data sourced from ClinicalTrials.gov (NCT03359811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.