Clinical trial NCT03972397: Intercostal Nerve Cryoablation for Postoperative Pain Management
Official title: Intercostal Nerve Cryoablation for Postoperative Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Cryoablation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Score on Numeric Pain Scale (NPS)
timeFrame: post-operative day 5
measure: Brief Pain Inventory (BPI) - Severity Score
timeFrame: baseline
measure: Brief Pain Inventory (BPI) - Severity Score
timeFrame: post-operative day 3
measure: Brief Pain Inventory (BPI) - Severity Score
timeFrame: post-operative day 4
measure: Brief Pain Inventory (BPI) - Severity Score
timeFrame: post-operative day 5
measure: Brief Pain Inventory (BPI) - Severity Score
timeFrame: post-operative day 30
measure: Brief Pain Inventory (BPI) - Severity Score
timeFrame: post-operative day 180
measure: Brief Pain Inventory (BPI) - Pain Interference Score
timeFrame: baseline
measure: Brief Pain Inventory (BPI) - Pain Interference Score
timeFrame: post-operative day 3
measure: Brief Pain Inventory (BPI) - Pain Interference Score
timeFrame: post-operative day 4
measure: Brief Pain Inventory (BPI) - Pain Interference Score
timeFrame: post-operative day 5
measure: Brief Pain Inventory (BPI) - Pain Interference Score
timeFrame: post-operative day 30
measure: Brief Pain Inventory (BPI) - Pain Interference Score
timeFrame: post-operative day 180
measure: 5-point Satisfaction Scale
timeFrame: post-operative day 3
measure: 5-point Satisfaction Scale
timeFrame: post-operative day 4
measure: 5-point Satisfaction Scale
timeFrame: post-operative day 5
measure: 5-point Satisfaction Scale
timeFrame: post-operative day 30
measure: 5-point Satisfaction Scale
timeFrame: post-operative day 180
Secondary outcomes:
measure: Total Amount in mg of Opioid Medication Consumed
timeFrame: third to fifth post-operative days after surgery
measure: Number of Participants Who Require of Opioids at the Time of Discharge
timeFrame: at the time of discharge (about a week after surgery)
measure: Number of Participants Who Utilize Patient-controlled Analgesia (PCA)
timeFrame: from the time immediately after surgery to post-operative day 3
measure: Amount of Patient-controlled Analgesia (PCA) Used
timeFrame: from the time immediately after surgery to post-operative day 3
measure: Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours
timeFrame: 72 hours after surgery
measure: Length of Hospital Stay
timeFrame: at the time of discharge (about a week after surgery)
measure: Hospital Cost for Patient Care During Hospitalization
timeFrame: at the time of discharge (about a week after surgery)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Anthony L Estrera, MD
role: PRINCIPAL_INVESTIGATOR
References: