Intercostal Nerve Cryoablation for Postoperative Pain Management
Purpose
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.
Eligibility
- Eligible Ages
-
Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
-
No
Inclusion Criteria
- Descending/thoracoabdominal incision is planned
- There is reasonable expectation that the patient will be extubated within 48 hours
after surgery
Exclusion Criteria
- The patient has a known allergy to morphine or any opioid
- The patient has a known chronic pain disorder or takes daily opioid medication > 1
month prior to surgery
- The surgeon/anesthesiologist concludes that the period for intubation will be likely
be for more than 48 hours after surgery There is anticipated difficulty communicating
pain status due to language or other barriers at the investigator discretion.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
Arm | Description | Assigned Intervention |
Experimental Intercostal Nerve Cryoablation plus SOC Pain Control
|
Standard of Care (SOC)
|
-
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 names:
- 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 names:
- 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.
|
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 names:
- 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.
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston
Study Contact