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Intercostal Nerve Cryoablation for Postoperative Pain Management

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ClinicalTrials.gov Identifier: NCT03972397
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony L Estrera, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Device: Intercostal Nerve Cryoablation Drug: Bupivacaine liposomal injectable suspension Drug: Patient-controlled analgesia (PCA) Phase 4

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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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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.

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.




Primary Outcome Measures :
  1. Score on Numeric Pain Scale (NPS) [ Time Frame: post-operative day 5 ]
    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.

  2. Brief Pain Inventory (BPI) - severity score [ Time Frame: baseline ]
    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.

  3. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 3 ]
    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.

  4. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 4 ]
    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.

  5. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 5 ]
    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.

  6. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 30 ]
    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.

  7. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 180 ]
    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.

  8. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: baseline ]
    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.

  9. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 3 ]
    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.

  10. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 4 ]
    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.

  11. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 5 ]
    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.

  12. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 30 ]
    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.

  13. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 180 ]
    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.

  14. 5-point satisfaction scale [ Time Frame: post-operative day 3 ]
    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".

  15. 5-point satisfaction scale [ Time Frame: post-operative day 4 ]
    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".

  16. 5-point satisfaction scale [ Time Frame: post-operative day 5 ]
    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".

  17. 5-point satisfaction scale [ Time Frame: post-operative day 30 ]
    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".

  18. 5-point satisfaction scale [ Time Frame: post-operative day 180 ]
    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".


Secondary Outcome Measures :
  1. Total amount in mg of opioid medication consumed [ Time Frame: third to fifth post-operative days after surgery ]
  2. Number of participants who require of opioids at the time of discharge [ Time Frame: at the time of discharge (about a week after surgery) ]
  3. Number of participants who utilize patient-controlled analgesia (PCA) [ Time Frame: from the time immediately after surgery to post-operative day 3 ]
  4. Amount of patient-controlled analgesia (PCA) used [ Time Frame: from the time immediately after surgery to post-operative day 3 ]
  5. Number of participants who attain physical therapy goal that justifies discharge from inpatient physical therapy within 72 hours [ Time Frame: 72 hours after surgery ]
  6. Length of hospital stay [ Time Frame: at the time of discharge (about a week after surgery) ]
  7. Hospital cost for patient care during hospitalization [ Time Frame: at the time of discharge (about a week after surgery) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972397


Contacts
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Contact: Alexis Offner, MPH 713-486-5131 Alexis.D.Offner@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Alexis Offner, MPH    713-486-5100    Alexis.D.Offner@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Anthony L Estrera, MD The University of Texas Health Science Center, Houston

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Responsible Party: Anthony L Estrera, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03972397     History of Changes
Other Study ID Numbers: HSC-MS-19-0283
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anthony L Estrera, The University of Texas Health Science Center, Houston:
Cryoablation

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents