Intercostal Nerve Cryoablation for Postoperative Pain Management
Overview
- Phase
- Phase 4
- Intervention
- Intercostal Nerve Cryoablation
- Conditions
- Pain, Postoperative
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 5-point Satisfaction Scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Anthony L Estrera
Professor
The University of Texas Health Science Center, Houston
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.
Arms & Interventions
Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
Intervention: Intercostal Nerve Cryoablation
Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
Intervention: Bupivacaine liposomal injectable suspension
Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
Intervention: Patient-controlled analgesia (PCA)
Standard of Care (SOC) Pain Control
Intervention: Bupivacaine liposomal injectable suspension
Standard of Care (SOC) Pain Control
Intervention: Patient-controlled analgesia (PCA)
Outcomes
Primary Outcomes
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".
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.
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.
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.
Secondary Outcomes
- 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))