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

NCT03359811 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2017-0492NCI-2018-00999
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 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

Peritoneal Cancer

Keywords

Local Anesthetic Solution; Bupivacaine HCl; Liposomal Bupivacaine; Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2

  To compare the efficacy of 4 quadrants TAP blocks (4Q-TAP) versus Thoracic Epidural Analgesia (routine care) on the quality of recovery 48 hours after CRS-HIPEC surgery, measure by QoR-15 changes from Pre-Op to POD2. The QoR scale is a validated scoring system that allows for the quantification of a patient's early postoperative health status. The minimum score 0 and maximum score 150. The higher score mean a better outcome.

  48 hours after CRS-HIPEC surgery

Secondary Outcomes (6)

• 4Q-TAP Versus TEA on Postoperative Pain

  48 hours after CRS-HIPEC surgery

• Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA

  During the 48 hours after CRS-HIPEC surgery

• Comparison of the Length of Stay (LOS) Between Patients With 4Q-TAP Versus TEA

  Length of stay calculated from day of surgery to date of hospital discharge, up to 46 days

• Number of Participants With Adverse Events Related to 4Q-TAP Versus TEA

  48 hours after CRS-HIPEC surgery

• Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48

  Within the first 48 hours after the end of CRS-HIPEC surgery

Study Arms (2)

Standard-of-Care Thoracic Epidural Analgesia (TEA)

EXPERIMENTAL

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.

Drug: Local Anesthetic Solution

4Q-TAP Blocks

ACTIVE COMPARATOR

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.

Drug: Bupivacaine HCl; Drug: Liposomal Bupivacaine

Interventions

Local Anesthetic Solution DRUG

A bolus or infusion of local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.

Standard-of-Care Thoracic Epidural Analgesia (TEA)

Bupivacaine HCl DRUG

30 mg of Bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) injected before surgical incision in each of the four quadrants.

4Q-TAP Blocks

Liposomal Bupivacaine DRUG

65 mg of Liposomal Bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.

Also known as: EXPAREL

4Q-TAP Blocks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Juan Cata, MD, Associate Professor, Anesthesiology & PeriOper Med
• Organization: UT MD Anderson Cancer Center

jcata@mdanderson.org

(713) 792-7452

Study Officials

• Juan P. Cata, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: November 27, 2017
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: February 18, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-01

Locations

US (1)