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

NCT05276258 | Unknown FDA Device

• 1 other identifier: PRO00029370
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Opioid Use Within 24 Hours After Chest Tube Removal

  Opioid use measured as the daily dose of milligram morphine equivalents (MME)

  From the time of chest tube removal to 24 hours after chest tube removal

Secondary Outcomes (9)

• Total Emergent Adverse Effects (TEAE)

  Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery

• Length of Hospital Stay

  From admission to discharge or death, up to 1 year after surgery

• Mean Cost of Hospital Care

  From admission to discharge or death, up to 1 year after surgery

• Number of Readmissions

  From initial admission for surgery to 28 days after surgery

• Neuroma Formation

  Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery

Study Arms (2)

Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation

EXPERIMENTAL

The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital.

Device: cryoSPHERE Ablation; Drug: Bupivacaine

Historical Controls

OTHER

A total of 75 propensity score-matched historical controls will be selected from the pool of patients who had standard intercostal nerve block using liposomal bupivacaine alone at Houston Methodist Hospital from January 1, 2017 through January 1, 2022, inclusively.

Drug: Bupivacaine

Interventions

cryoSPHERE Ablation DEVICE

The cryoSPHERE probe will be introduced through a thoracoscopic port and placed inferior to each rib level and 2cm lateral and away from the sympathetic chain when clearly visible or 4cm lateral and away from the spine when the sympathetic chain is not visible. Levels to be ablated are intercostal spaces 3-9. Each intercostal nerve will undergo cryogenic ablation of -70 degrees Celsius for 120 seconds. The probe will be firmly pushed against the nerve for 120 seconds and will only be released from the nerve when the probe has thawed. Axons within the intercostal nerve that send pain signals will be destroyed distal to the cryoablation site. However, the tubules structures (epineurium, perineurium, and endoneurium) of the nerve will remain intact, allowing the axons to regenerate and nerve function to resume after one to three months.

Also known as: cryoSPHERE

Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation

Bupivacaine DRUG

A long needle will be introduced through a thoracoscopic port, and in each intercostal space (1-11), 1ml of liposomal bupivacaine will be injected onto the intercostal nerves to induce intercostal nerve blockage.

Also known as: liposomal bupivacaine, Exparel

Historical Controls; Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 29708130 BACKGROUND

• 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.

  PMID: 25912739 BACKGROUND

• 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.

  PMID: 32038918 BACKGROUND

• 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.

  PMID: 32142814 BACKGROUND

• 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.

  PMID: 29607171 BACKGROUND

• AtriCure, I., croSPHERE Probe Package Insert.

  BACKGROUND

• 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.

  PMID: 30935731 BACKGROUND

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia; Neuroma

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Min Kim, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Surgery

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 11, 2022
• Study Start: February 1, 2023
• Primary Completion: March 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)