PainNCT05276258
Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients
A study testing cryoSPHERE Ablation and Bupivacaine in people with Pain and Pain, Postoperative, run by The Methodist Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Pain, Postoperative
- What is being tested?
- cryoSPHERE Ablation and Bupivacaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
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
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.
Read the 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.
- Conditions
- Pain, Pain, Postoperative
- Being tested
- cryoSPHERE Ablation, Bupivacaine
- Keywords
- pain management, pulmonary surgical procedures, robotic surgical procedures, pneumonectomy, nerve block, neuroma, analgesics, opioid, bupivacaine, length of stay, drug tolerance
- Medical subject headings
- Pain, Pain, Postoperative, Agnosia, Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoSPHERE AblationDevice
Also called cryoSPHERE
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.
BupivacaineDrug
Also called liposomal bupivacaine, Exparel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use Within 24 Hours After Chest Tube Removal
Opioid use measured as the daily dose of milligram morphine equivalents (MME)
Measured: From the time of chest tube removal to 24 hours after chest tube removal
Secondary outcomes (9)
Total Emergent Adverse Effects (TEAE)
Morbidity, defined as total emergent adverse effects (TEAE) for the experimental group vs. control
Measured: 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
Time spent in the hospital from admission for surgery until discharge or death
Measured: From admission to discharge or death, up to 1 year after surgery
Mean Cost of Hospital Care
Total cost of billed medical care for the surgery
Measured: From admission to discharge or death, up to 1 year after surgery
Number of Readmissions
The number of readmissions to the hospital
Measured: From initial admission for surgery to 28 days after surgery
Neuroma Formation
The formation of a neuroma around the site of nerve block administration
Measured: Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery
Pain Score
Patient's perceived pain level on a scale of 1 to 10
Measured: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
PROMIS3a Pain Intensity
Patient's perceived pain level on a scale of 3-15, per PROMIS Pain Intensity Short Form 3a v1.0
Measured: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
PROMIS8a Pain Interference
Patient's perceived pain interference level on a scale of 8-40, per PROMIS Pain Interference Adult Form
Measured: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
Opioid Use after Surgery
Mean daily opioid use after surgery measured in milligram morphine equivalents (MME)
Measured: Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Feb 2023
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min P. Kim, MD, The Methodist Hospital Research Institute
- Investigators
- Min Kim, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276258
- Sponsor's protocol ID
- PRO00029370
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29708130Rice 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.
PubMed 25912739Nobel 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.
PubMed 32038918Brown 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.
PubMed 32142814Kim 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.
PubMed 29607171AtriCure, I., croSPHERE Probe Package Insert.
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.
PubMed 30935731
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05276258
- Acronym / sponsor ID
- PRO00029370
- Conditions
- Pain, Pain, Postoperative
- Keywords
- pain management, pulmonary surgical procedures, robotic surgical procedures, pneumonectomy, nerve block, neuroma, analgesics, opioid, bupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation | Experimental | Device: cryoSPHERE Ablation, Drug: BupivacaineThe 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. |
| Historical Controls | Other | Drug: BupivacaineA 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous major surgery at the operative site (thoracotomy)
- Allergy to aluminum
- Allergy to plastics
- Allergy to bupivacaine
- Shingles disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoSPHERE AblationAlso: cryoSPHEREThe 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. | Device | Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation |
| BupivacaineAlso: liposomal bupivacaine, ExparelA 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. | Drug | Historical Controls, Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation |
Primary outcome
Opioid Use Within 24 Hours After Chest Tube Removal
Time frame: 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)
9 secondary outcomes
Total Emergent Adverse Effects (TEAE)
Time frame: 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
Time frame: From admission to discharge or death, up to 1 year after surgery
Mean Cost of Hospital Care
Time frame: From admission to discharge or death, up to 1 year after surgery
Number of Readmissions
Time frame: From initial admission for surgery to 28 days after surgery
Neuroma Formation
Time frame: Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery
Pain Score
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
PROMIS3a Pain Intensity
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
PROMIS8a Pain Interference
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
Opioid Use after Surgery
Time frame: Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 29708130Goto 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.
- Background: PubMed 25912739Rice 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.
- Background: PubMed 32038918Nobel 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.
- Background: PubMed 32142814Brown 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.
- Background: PubMed 29607171Kim 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.
- BackgroundAtriCure, I., croSPHERE Probe Package Insert.
- Background: PubMed 30935731Graves 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Kim, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoSPHERE Ablation and Bupivacaine in people with Pain and Pain, Postoperative, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use Within 24 Hours After Chest Tube Removal (time frame: From the time of chest tube removal to 24 hours after chest tube removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276258, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.