Clinical trial NCT05276258: Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients
Official title: A Randomized Controlled Trial of cryoSPHERE (CRYOS/CRYOS-L) Ablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients Undergoing Robotic-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain
Pain, Postoperative
Keywords: pain management
pulmonary surgical procedures
robotic surgical procedures
pneumonectomy
nerve block
neuroma
analgesics, opioid
bupivacaine
length of stay
drug tolerance
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.

Detailed description: Patients who take more opioid medications after surgery tend to have longer hospital stays, and they are at risk of developing pneumonia and other postoperative morbidities. Opioid-tolerant patients are at a higher risk of developing these morbidities because they often require higher doses of opioid medications to manage their post-operative pain. Reducing post-operative pain in these patients through non-opioid means helps reduce their risk of developing morbidities, and is potentially a more effective form of pain management, particularly in this patient population.

This is a single-center, prospective cohort registry with a historical control, and an estimated duration of 2 years. This study's primary objective is to evaluate the cryoSPHERE probe for ablation in pain control after surgery (measured using opioid medication). The secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation.

We plan to recruit 75 patients who will receive the cryoSPHERE probe and compare them to 75 patients who did not receive the cryoSPHERE probe. The experimental group will receive cryoSPHERE ablation of intercostal nerves and liposomal bupivacaine. The historical control group will have had robotic-assisted thoracoscopic surgery and an intercostal nerve block with liposomal bupivacaine and no cyroSPHERE probe.

Eligibility criteria: Inclusion Criteria:

* Male and female patients 18-90 years of age
* Diagnosis requiring robotic-assisted thoracoscopic surgery
* Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment
* Experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.

Exclusion Criteria:

* Previous major surgery at the operative site (thoracotomy)
* Allergy to aluminum
* Allergy to plastics
* Allergy to bupivacaine
* Shingles disease
* Demyelinating illnesses
* Involvement with other interventional studies

Primary outcomes:
measure: Opioid Use Within 24 Hours After Chest Tube Removal
timeFrame: From the time of chest tube removal to 24 hours after chest tube removal
Secondary outcomes:
measure: Total Emergent Adverse Effects (TEAE)
timeFrame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
measure: Length of Hospital Stay
timeFrame: From admission to discharge or death, up to 1 year after surgery
measure: Mean Cost of Hospital Care
timeFrame: From admission to discharge or death, up to 1 year after surgery
measure: Number of Readmissions
timeFrame: From initial admission for surgery to 28 days after surgery
measure: Neuroma Formation
timeFrame: Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery
measure: Pain Score
timeFrame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
measure: PROMIS3a Pain Intensity
timeFrame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
measure: PROMIS8a Pain Interference
timeFrame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
measure: Opioid Use after Surgery
timeFrame: Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Min Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goto T. What is the best pain control after thoracic surgery? J Thorac Dis. 2018 Mar;10(3):1335-1338. doi: 10.21037/jtd.2018.03.63. No abstract available.
citation: Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.
citation: Nobel TB, Adusumilli PS, Molena D. Opioid use and abuse following video-assisted thoracic surgery (VATS) or thoracotomy lung cancer surgery. Transl Lung Cancer Res. 2019 Dec;8(Suppl 4):S373-S377. doi: 10.21037/tlcr.2019.05.14. No abstract available.
citation: Brown LM, Kratz A, Verba S, Tancredi D, Clauw DJ, Palmieri T, Williams D. Pain and Opioid Use After Thoracic Surgery: Where We Are and Where We Need To Go. Ann Thorac Surg. 2020 Jun;109(6):1638-1645. doi: 10.1016/j.athoracsur.2020.01.056. Epub 2020 Mar 3.
citation: Kim MP, Chan EY, Meisenbach LM, Dumitru R, Brown JK, Masud FN. Enhanced recovery after thoracic surgery reduces discharge on highly dependent narcotics. J Thorac Dis. 2018 Feb;10(2):984-990. doi: 10.21037/jtd.2018.01.99.
citation: AtriCure, I., croSPHERE Probe Package Insert.
citation: Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.