Intercostal Nerve Cryoablation for Postoperative Pain Management

Pain, Postoperative Clinical Trial

Official title:

Intercostal Nerve Cryoablation for Postoperative Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972397
• Other study ID #: HSC-MS-19-0283
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2019
• Est. completion date: September 22, 2022

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• Intercostal Nerve Cryoablation
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.

Drug:
• Bupivacaine liposomal injectable suspension
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).
• Patient-controlled analgesia (PCA)
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Total Amount in mg of Opioid Medication Consumed		third to fifth post-operative days after surgery
Secondary	Number of Participants Who Require of Opioids at the Time of Discharge		at the time of discharge (about a week after surgery)
Secondary	Number of Participants Who Utilize Patient-controlled Analgesia (PCA)		from the time immediately after surgery to post-operative day 3
Secondary	Amount of Patient-controlled Analgesia (PCA) Used		from the time immediately after surgery to post-operative day 3
Secondary	Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours		72 hours after surgery
Secondary	Length of Hospital Stay		at the time of discharge (about a week after surgery)
Secondary	Hospital Cost for Patient Care During Hospitalization		at the time of discharge (about a week after surgery)