Intercostal Nerve Cryoablation for Postoperative Pain Management

Study Overview
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Brief Summary
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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.

Official Title
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Intercostal Nerve Cryoablation for Postoperative Pain Management

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Intercostal Nerve Cryoablation
* Drug: Bupivacaine liposomal injectable suspension
* Drug: Patient-controlled analgesia (PCA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intercostal Nerve Cryoablation plus SOC Pain Control<br>Standard of Care (SOC) | Device: Intercostal Nerve Cryoablation<br>* 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.<br>* Other names: CryoICE® CRYO2 cryoablation probes (AtriCure, Inc);Drug: Bupivacaine liposomal injectable suspension<br>* 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).<br>* Other names: Exparel® (Pacira Pharmacoceuticals);Drug: Patient-controlled analgesia (PCA)<br>* 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.<br>|
| Active Comparator: Standard of Care (SOC) Pain Control<br> | Drug: Bupivacaine liposomal injectable suspension<br>* 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).<br>* Other names: Exparel® (Pacira Pharmacoceuticals);Drug: Patient-controlled analgesia (PCA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Numeric Pain Scale (NPS) | The NPS measures the intensity of pain. The total score ranges from 0 to 10, with 0 being no pain and 10 the highest pain. | post-operative day 5 | 
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | baseline | 
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 3 | 
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 4 | 
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 5 | 
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 30 | 
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 180 | 
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | baseline | 
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 3 | 
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 4 | 
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 5 | 
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 30 | 
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 180 | 
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. | post-operative day 3 | 
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. | post-operative day 4 | 
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. | post-operative day 5 | 
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. | post-operative day 30 | 
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. | post-operative day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount in mg of Opioid Medication Consumed |  | third to fifth post-operative days after surgery | 
| Number of Participants Who Require of Opioids at the Time of Discharge |  | at the time of discharge (about a week after surgery) | 
| Number of Participants Who Utilize Patient-controlled Analgesia (PCA) |  | from the time immediately after surgery to post-operative day 3 | 
| Amount of Patient-controlled Analgesia (PCA) Used |  | from the time immediately after surgery to post-operative day 3 | 
| Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours |  | 72 hours after surgery | 
| Length of Hospital Stay |  | at the time of discharge (about a week after surgery) | 
| Hospital Cost for Patient Care During Hospitalization |  | at the time of discharge (about a week after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation