A Phase 3 interventional study of Local Anesthetic Solution and Bupivacaine HCl in Peritoneal Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Treatment
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:
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 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:
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.
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
30 mg of Bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) injected before surgical incision in each of the four quadrants.
65 mg of Liposomal Bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
Also known as: EXPAREL
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.
Time frame: 48 hours after CRS-HIPEC surgery
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.
Time frame: 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.
Time frame: 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.
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
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.
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
Opioid-related adverse (i.e. respiratory depression, pruritus, sedation, delirium) within the first 48 hours after the end of surgery.
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
Postoperative complications recorded using Clavien-Dindo scale and POMS.
Time frame: 48 hours after CRS-HIPEC surgery
Patients were recruited from November 2017 to February 2020.
| Milestone | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Started | 35 | 35 |
| Completed | 33 | 35 |
| Not completed | 2 | 0 |
| Withdrew: Protocol violation | 2 | 0 |
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.
| score on a scale | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2 | -45 (-89 to 0) | -50 (-88 to 23) |
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.
| score on a scale | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Pain at Rest | 3 (0 to 10) | 4 (0 to 10) |
| Pain with Cough | 5 (1 to 10) | 5 (1 to 10) |
Opioid Consumption reported as morphine equivalents required during the 48 hours after the end of surgery.
| morphine milligram equivalents (MME) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA | 4.5 (0 to 51) | 21 (1.8 to 108.8) |
Length of stay calculated from day of surgery to date of hospital discharge.
| days | Standard-of-Care Thoracic Epidural Analgesia (TEA) | 4Q-TAP Blocks |
|---|---|---|
| Comparison of the Length of Stay (LOS) Between Patients With 4Q-TAP Versus TEA | 11 (4 to 24) | 11 (4 to 46) |
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.
| Participants | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Number of Participants With Adverse Events Related to 4Q-TAP Versus TEA | 3 | 1 |
Opioid-related adverse (i.e. respiratory depression, pruritus, sedation, delirium) within the first 48 hours after the end of surgery.
| Participants | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48 | 7 | 7 |
Postoperative complications recorded using Clavien-Dindo scale and POMS.
| Participants | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Pulmonary Complications | 5 | 8 |
| Renal Complications | 5 | 5 |
| Gastrointestinal Complications | 1 | 0 |
| Cardiac Complications | 7 | 4 |
| Hematological Complications | 2 | 6 |
Collected over Adverse event data were collected within the first 48 hours after end of surgery, up to 30 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard-of-Care Thoracic Epidural Analgesia (TEA) | 0/33 (0%) | 0/33 (0%) | 17/33 (51.5%) |
| Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | 0/35 (0%) | 1/35 (2.9%) | 16/35 (45.7%) |
| Event | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| Intraabdominal AbscessGeneral disorders | 0/33 | 1/35 |
| Event | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block |
|---|---|---|
| NauseaGastrointestinal disorders | 17/33 | 16/35 |
| HypotensionCardiac disorders | 14/33 | 8/35 |
| Dry mouthGastrointestinal disorders | 2/33 | 4/35 |
| PruritusSkin and subcutaneous tissue disorders | 3/33 | 3/35 |
| SedationGeneral disorders | 2/33 | 0/35 |
| IleusGastrointestinal disorders | 1/33 | 0/35 |
| Low urinary inputRenal and urinary disorders | 1/33 | 1/35 |
Baseline demographics data is only available for the participants who completed the study
| Age, Categorical(Participants) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 29 | 53 |
| >=65 years | 9 | 6 | 15 |
| Age, Continuous(years) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| Median | 58 (20 to 74) | 57 (25 to 72) | 58 (20 to 74) |
| Sex: Female, Male(Participants) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| Female | 18 | 21 | 39 |
| Male | 15 | 14 | 29 |
| Race and Ethnicity Not Collected(Participants) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| United States | 33 | 35 | 68 |
| Median BMI(kg/m^2) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| Median | 26.6 (16.5 to 47.9) | 25.4 (19.3 to 51.3) | 26.6 (16.5 to 51.3) |
| History of Depression(Participants) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| No | 27 | 27 | 54 |
| Yes | 6 | 8 | 14 |
| Preoperative antidepressants(Participants) | Standard-of-Care Thoracic Epidural Analgesia (TEA) | Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block | Total |
|---|---|---|---|
| No | 27 | 28 | 55 |
| Yes | 6 | 7 | 13 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Nov 2020, 35 months.
Results were first posted in Feb 2022, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Local anesthetics