Intercostal Nerve Cryoablation for Postoperative Pain Management
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2022
CompletedResults Posted
Study results publicly available
November 2, 2023
CompletedNovember 2, 2023
October 1, 2023
3.2 years
May 30, 2019
September 22, 2023
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Intercostal Nerve Cryoablation plus SOC Pain Control
EXPERIMENTALStandard of Care (SOC)
Standard of Care (SOC) Pain Control
ACTIVE COMPARATORInterventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- Descending/thoracoabdominal incision is planned
- There is reasonable expectation that the patient will be extubated within 48 hours after surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anthony L Estrera, MD
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony L Estrera, MD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 3, 2019
Study Start
July 15, 2019
Primary Completion
September 22, 2022
Study Completion
September 22, 2022
Last Updated
November 2, 2023
Results First Posted
November 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share