Peritoneal CancerPhase 3NCT03359811
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 Phase 3 study testing Local Anesthetic Solution, Bupivacaine HCl and Liposomal Bupivacaine in people with Peritoneal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Cancer
- What is being tested?
- Local Anesthetic Solution, Bupivacaine HCl and Liposomal Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 24 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Peritoneal Cancer
- Being tested
- Local Anesthetic Solution, Bupivacaine HCl, Liposomal Bupivacaine
- Keywords
- Local Anesthetic Solution, Bupivacaine HCl, Liposomal Bupivacaine, Peritoneal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthetic SolutionDrug
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.
Bupivacaine HClDrug
30 mg of Bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) injected before surgical incision in each of the four quadrants.
Liposomal BupivacaineDrug
Also called EXPAREL
65 mg of Liposomal Bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine HCl; Drug: Liposomal Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after CRS-HIPEC surgery
Secondary outcomes (6)
4Q-TAP Versus TEA on Postoperative Pain
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.
Measured: 48 hours after CRS-HIPEC surgery
Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA
Opioid Consumption reported as morphine equivalents required during the 48 hours after the end of surgery.
Measured: 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.
Measured: 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
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.
Measured: 48 hours after CRS-HIPEC surgery
Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48
Opioid-related adverse (i.e. respiratory depression, pruritus, sedation, delirium) within the first 48 hours after the end of surgery.
Measured: Within the first 48 hours after the end of CRS-HIPEC surgery
Number of Participants With Incidence of Postoperative Complications and Morbidity in Patients Receiving 4Q-TAP Versus TEA
Postoperative complications recorded using Clavien-Dindo scale and POMS.
Measured: 48 hours after CRS-HIPEC surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start27 Nov 2017
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peritoneal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan P. Cata, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359811
- Sponsor's protocol ID
- 2017-0492
- Other IDs
- NCI-2018-00999
- Status last verified
- Jan 2022
- First submitted
- 27 Nov 2017
- Last updated
- 18 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03359811
- Acronym / sponsor ID
- 2017-0492
- Conditions
- Peritoneal Cancer
- Keywords
- Local Anesthetic Solution, Bupivacaine HCl, Liposomal Bupivacaine, Peritoneal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care Thoracic Epidural Analgesia (TEA) | Experimental | Drug: Local Anesthetic SolutionAn 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. |
| 4Q-TAP Blocks | Active comparator | Drug: Bupivacaine HCl, Drug: Liposomal BupivacaineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Anesthetic SolutionA bolus or infusion of local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment. | Drug | Standard-of-Care Thoracic Epidural Analgesia (TEA) |
| Bupivacaine HCl30 mg of Bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) injected before surgical incision in each of the four quadrants. | Drug | 4Q-TAP Blocks |
| Liposomal BupivacaineAlso: EXPAREL65 mg of Liposomal Bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants. | Drug | 4Q-TAP Blocks |
Primary outcome
Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2
Time frame: 48 hours after CRS-HIPEC surgery
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.
6 secondary outcomes
4Q-TAP Versus TEA on Postoperative Pain
Time frame: 48 hours after CRS-HIPEC surgery
Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA
Time frame: During the 48 hours after CRS-HIPEC surgery
Comparison of the Length of Stay (LOS) Between Patients With 4Q-TAP Versus TEA
Time frame: 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
Time frame: 48 hours after CRS-HIPEC surgery
Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48
Time frame: Within the first 48 hours after the end of CRS-HIPEC surgery
Number of Participants With Incidence of Postoperative Complications and Morbidity in Patients Receiving 4Q-TAP Versus TEA
Time frame: 48 hours after CRS-HIPEC surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P. Cata, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Local Anesthetic Solution, Bupivacaine HCl and Liposomal Bupivacaine in people with Peritoneal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2 (time frame: 48 hours after CRS-HIPEC surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022; AzTrials last refreshed its copy on 2 Nov 2026.