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Bupivacaine

Anesthetics, Local

Analgesics, Opioid

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.

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.

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.

Local Anesthetic Solution

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

Bupivacaine HCl

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

Liposomal Bupivacaine

Juan P. Cata, MD

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.

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 routine tests.
* Participant will complete a questionnaire about the quality of recovery. Participant's responses before surgery will be compared to participant's responses after surgery. It should take about 5 minutes to complete.

Study Groups/Procedures:

Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups on the morning of participant's surgery. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If participant is in Group 1, participant will receive standard-of-care TEA before participant goes to sleep.
* If participant is in Group 2, participant will receive the 4Q-TAP block injections after participant is asleep.

If participant is in Group 1, participant will have a catheter placed in participant's back before surgery so that the TEA can be infused. If needed, participant may receive an injection of numbing medication and/or pain medication before the catheter is placed. Participant will sign a separate consent for the placement of the catheter.

If participant is in Group 2, participant will receive up to four (4) injections of 4Q-TAP block directly into different parts of the abdomen. These injections will take place after participant has been given general anesthesia. An ultrasound will be used to guide these injections. Participant will not be awake for these injections.

Both groups will sign a separate consent for the surgery that explains the procedures and the risks. Participant may receive standard drugs during surgery. The study staff can tell participant about the risks of these drugs and how they are given.

For both groups, information about the surgery will be collected while participant is in the operating room.

Post-Surgery:

After surgery, participant will receive standard drugs for pain as needed. Participant will be asked to complete a questionnaire about the quality of participant's recovery on the following days after surgery:

* Days 1-3
* Day 5
* Day 7
* Day 10 and
* Day 30

The questionnaire should take about 5 minutes each time. Participant will complete the questionnaire in person or participant will be called on the phone to complete it if participant has already left the hospital.

On Days 1, 2, and 7 after surgery, blood (about 8 teaspoons each time) will be drawn for routine tests.

After participant leaves the hospital, researchers will collect information from participant's medical record about participant's standard follow-up visits.

Length of Study Participation:

Active participation in this study will be complete 30 days after the surgery.

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

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.

Pain intensity at rest and cough measure using a Validity and Reliability of the Verbal Numerical Rating Scale (VNRS) (0 = no pain - 10 = worst pain ever). Higher numerical scores on the scale indicate more pain, thus a worse outcome. Data reported as time-weighted pain scores from discharge from the PACU until 48 hours after the end of surgery.

Opioid Consumption reported as morphine equivalents required during the 48 hours after the end of surgery.

Length of stay calculated from day of surgery to date of hospital discharge.

An adverse event is any symptom, sign, illness, or experience which develops or worsens during the course of the study, whether or not the event is considered related to study drug. Adverse events (AEs) related to the study interventions recorded within the first 48 hours after the end of surgery.

Opioid-related adverse (i.e. respiratory depression, pruritus, sedation, delirium) within the first 48 hours after the end of surgery.

Postoperative complications recorded using Clavien-Dindo scale and POMS.

M.D. Anderson Cancer Center

Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.

Standard-of-Care Thoracic Epidural Analgesia (TEA)

Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Median BMI

History of Depression

Preoperative antidepressants

Preoperative Opioids

Median Anesthesia Duration

Volatile anesthesia

Median propofol consumption

Dexmedetomidine use

Median Crystalloids use

Red blood cell transfusion intraoperatively

Frozen plasma transfusions intraoperatively

Perfusion completed

Urinary output

Baseline demographics data is only available for the participants who completed the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Peritoneal Canc...	Local Anestheti... Bupivacaine HCl Liposomal Bupiv...	18 Years -	M.D. Anderson Cancer Center
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	Peritoneal Canc...	Local Anestheti... Bupivacaine HCl Liposomal Bupiv...	18 Years -	M.D. Anderson Cancer Center

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