Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients

Pain Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

• NCT number: NCT05276258
• Study type: Interventional
• Source: The Methodist Hospital Research Institute
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2023
• Completion date: September 15, 2025