Condition or disease | Intervention/treatment | Phase |
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Pain, Postoperative | Device: Intercostal Nerve Cryoablation Drug: Bupivacaine liposomal injectable suspension Drug: Patient-controlled analgesia (PCA) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Intercostal Nerve Cryoablation for Postoperative Pain Management |
Actual Study Start Date : | July 15, 2019 |
Estimated Primary Completion Date : | August 1, 2021 |
Estimated Study Completion Date : | August 1, 2021 |
Arm | Intervention/treatment |
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Experimental: Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
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Device: Intercostal Nerve Cryoablation
Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.
Other Name: CryoICE® CRYO2 cryoablation probes (AtriCure, Inc)
Drug: Bupivacaine liposomal injectable suspension Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).
Other Name: Exparel® (Pacira Pharmacoceuticals)
Drug: Patient-controlled analgesia (PCA) Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.
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Active Comparator: Standard of Care (SOC) Pain Control |
Drug: Bupivacaine liposomal injectable suspension
Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).
Other Name: Exparel® (Pacira Pharmacoceuticals)
Drug: Patient-controlled analgesia (PCA) Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joshua Wong, MBE | 713-486-5131 | Joshua.wong@uth.tmc.edu |
United States, Texas | |
The University of Texas Health Science Center at Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Joshua Wong, MBE 713-486-5131 Joshua.wong@uth.tmc.edu |
Principal Investigator: | Anthony L Estrera, MD | The University of Texas Health Science Center, Houston |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 30, 2019 | ||||||
First Posted Date ICMJE | June 3, 2019 | ||||||
Last Update Posted Date | April 6, 2021 | ||||||
Actual Study Start Date ICMJE | July 15, 2019 | ||||||
Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Intercostal Nerve Cryoablation for Postoperative Pain Management | ||||||
Official Title ICMJE | Intercostal Nerve Cryoablation for Postoperative Pain Management | ||||||
Brief Summary | The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the magnitude and duration of postoperative pain control both in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Pain, Postoperative | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 1, 2021 | ||||||
Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03972397 | ||||||
Other Study ID Numbers ICMJE | HSC-MS-19-0283 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Anthony L Estrera, The University of Texas Health Science Center, Houston | ||||||
Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | The University of Texas Health Science Center, Houston | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |