Intercostal Nerve Cryoablation for Postoperative Pain Management

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: Intercostal Nerve Cryoablation; Drug: Bupivacaine liposomal injectable suspension; Drug: Patient-controlled analgesia (PCA)

• Registration Number: NCT03972397
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-06-03
• Study Start: 2019-07-15
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-22
• Results First Submitted: 2023-09-22
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Results First Posted: 2023-11-02
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intercostal Nerve Cryoablation plus SOC Pain Control	Bupivacaine liposomal injectable suspension	Standard of Care (SOC)
Intercostal Nerve Cryoablation plus SOC Pain Control	Intercostal Nerve Cryoablation	Standard of Care (SOC)
Intercostal Nerve Cryoablation plus SOC Pain Control	Patient-controlled analgesia (PCA)	Standard of Care (SOC)
Standard of Care (SOC) Pain Control	Bupivacaine liposomal injectable suspension	-
Standard of Care (SOC) Pain Control	Patient-controlled analgesia (PCA)	-

Primary Outcome Measures

Name	Time	Method
5-point Satisfaction Scale	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)	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	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	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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States