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
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | November 27, 2017 |
End Date: | November 2022 |
Contact: | Juan P. Cata, MD |
Email: | CR_Study_Registration@mdanderson.org |
Phone: | 713-792-4582 |
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
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.
(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.
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.
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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