Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients
Study Details
Study Description
Brief Summary
The main objective is to evaluate the efficacy of cryoSPHERE ablation of intercostal nerves in improving post-operative pain after undergoing robotic assisted thoracoscopic anatomic lung resection in opioid-tolerant patients to address whether cryoSPHERE can help reduce the need for opioid drugs for postoperative pain management in the opioid-tolerant patient population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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, randomized, controlled single-blind trial, with 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) in a population of opioid-tolerant patients.
The secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation. We plan to recruit 150 patients who will be randomized into two arms (control and experimental). Both groups will receive an intercostal nerve block with liposomal bupivacaine. The experimental group will also receive cryoSPHERE ablation of intercostal nerves.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation 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
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.
Other Names:
Drug: Bupivacaine
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.
Other Names:
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| Active Comparator: Nerve Block Using Liposomal Bupivacaine Alone The control group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine alone (standard approach) during robotic-assisted thoracoscopic operation at Houston Methodist Hospital. |
Drug: Bupivacaine
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Opioid Use Within 24 Hours After Chest Tube Removal [From the time of chest tube removal to 24 hours after chest tube removal]
Opioid use measured as the daily dose of milligram morphine equivalents (MME)
Secondary Outcome Measures
- 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]
Morbidity, defined as total emergent adverse effects (TEAE) for the experimental group vs. control
- Length of Hospital Stay [From admission to discharge or death, up to 1 year after surgery]
Time spent in the hospital from admission for surgery until discharge or death
- Mean Cost of Hospital Care [From admission to discharge or death, up to 1 year after surgery]
Total cost of billed medical care for the surgery
- Number of Readmissions [From initial admission for surgery to 28 days after surgery]
The number of readmissions to the hospital
- Neuroma Formation [Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery]
The formation of a neuroma around the site of nerve block administration
- Pain Score [Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery]
Patient's perceived pain level on a scale of 1 to 10
- Opioid Use after Surgery [Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery, and 6 months after surgery]
Mean daily opioid use after surgery measured in milligram morphine equivalents (MME)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female patients 18-90 years of age
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Diagnosis requiring robotic-assisted thoracoscopic surgery
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- Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery.
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Agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.
Exclusion Criteria:
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Previous major surgery at the operative site (thoracotomy)
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Allergy to aluminum
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Allergy to plastics
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Allergy to bupivacaine
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Shingles disease
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Demyelinating illnesses
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Involvement with other interventional studies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Houston Methodist Research Institute | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The Methodist Hospital Research Institute
Investigators
- Principal Investigator: Min Kim, MD, The Methodist Hospital Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- AtriCure, I., croSPHERE Probe Package Insert.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- PRO00029370