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Completed

NCT Number: NCT03972397

Intercostal Nerve Cryoablation for Postoperative Pain Management

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intercostal Nerve Cryoablation

Device

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)

Bupivacaine liposomal injectable suspension

Drug

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)

Patient-controlled analgesia (PCA)

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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