Cryotherapy EffectNCT05348447
Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
A study testing cryoanalgesia in people with Cryotherapy Effect and Pain, Postoperative, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection. There are two treatment groups in this study, a cryotherapy group and control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryotherapy Effect, Pain, Postoperative
- What is being tested?
- cryoanalgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 year and older.
- Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
- Performance status of 1 or 2.
Who cannot join
- Patients with ejection fraction less than 40%
- Patients with creatinine greater than 1.5.
- Patients with Child's B or C cirrhosis
- Patients on chronic narcotics for other reasons
- Patients diagnosed with fibromyalgia
- Patients who had previous thoracic surgery on the same side.
- Patients who cannot communicate in English.
- Patients unable to provide informed consent for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.
There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.
- Conditions
- Cryotherapy Effect, Pain, Postoperative
- Being tested
- cryoanalgesia, Standard of Care Pain Control
- Keywords
- pulmonary, resection, cryotherapy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoanalgesiaDevice
intraoperative intercostal nerve freezing for post-operative pain control
Standard of Care Pain ControlOther
Standard of Care Pain Control Post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Cryoanalgesia with standard of care pain control | Experimental | subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery Receives: Device: cryoanalgesia; Other: Standard of Care Pain Control |
| Standard of care pain control | Active comparator | subjects will receive standard of care pain control only Receives: Other: Standard of Care Pain Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine dose
total milligrams (mg) of morphine received during hospitalization
Measured: to discharge (up to 14 days)
Pain control
Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome
Measured: to discharge (up to 14 days)
Secondary outcomes (6)
pulmonary complications
Pulmonary complications as defined by the Society of Thoracic Surgeons database
Measured: through 1 year
pain control
Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome
Measured: 2 weeks and 3 months post-operatively
total morphine equivalent dose of narcotics
total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively
Measured: 2 weeks and 3 months post-operatively
Presence of neuropathy in the surgical site
physician will assess by modified treatment-induced neuropathy scale (0-10), with higher scores meaning a worse outcome; The modified questionnaire will assess the following symptoms and ask patients to score those symptoms from 0 (not present) to 10 (unbearable):
- Numbness at or near the incision site (including chest wall)
- Tingling at or near the incision site
- Pain at or near the incision site
- Hot or burning sensation at or near the incision site
- Feeling of coldness at or near the incision site
Measured: 2 weeks, 3 months, 6 months and 1 year postoperatively
Incentive Spirometer Volume
The highest number (breath volume) achieved on exhalation using the incentive spirometer
Measured: to discharge (up to 14 days)
Hospital length of stay
Number of days spent in hospital postoperatively
Measured: to discharge (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start21 Apr 2022
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Principal investigator, Benny Weksler, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348447
- Sponsor's protocol ID
- 2021-238
- Status last verified
- Feb 2026
- First submitted
- 15 Apr 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Drake L, Weksler B, Specht K, Kuchta P, Crist L, Williams BA, Fernando HC. Cryoanalgesia Increases Neuropathic Pain in Adults Undergoing Minimally Invasive Surgery: A 1-Year Follow-up of a Randomized Study. Ann Surg. 2026 Jun 1;283(6):943-949. doi: 10.1097/SLA.0000000000006973. Epub 2025 Nov 7.
PubMed 41199434
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
- ClinicalTrials.gov ID
- NCT05348447
- Acronym / sponsor ID
- 2021-238
- Conditions
- Cryotherapy Effect, Pain, Postoperative
- Keywords
- pulmonary, resection, cryotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 27 Apr 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.
This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.
There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoanalgesia with standard of care pain control | Experimental | Device: cryoanalgesia, Other: Standard of Care Pain Controlsubjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery |
| Standard of care pain control | Active comparator | Other: Standard of Care Pain Controlsubjects will receive standard of care pain control only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 year and older.
- Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
- Performance status of 1 or 2.
Key exclusion criteria (8 listed)
- Patients with ejection fraction less than 40%
- Patients with creatinine greater than 1.5.
- Patients with Child's B or C cirrhosis
- Patients on chronic narcotics for other reasons
- Patients diagnosed with fibromyalgia
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 |
|---|---|---|
| cryoanalgesiaintraoperative intercostal nerve freezing for post-operative pain control | Device | Cryoanalgesia with standard of care pain control |
| Standard of Care Pain ControlStandard of Care Pain Control Post-operatively | Other | Cryoanalgesia with standard of care pain control, Standard of care pain control |
Primary outcome
Total morphine dose
Time frame: to discharge (up to 14 days)
total milligrams (mg) of morphine received during hospitalization
Pain control
Time frame: to discharge (up to 14 days)
Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome
6 secondary outcomes
pulmonary complications
Time frame: through 1 year
pain control
Time frame: 2 weeks and 3 months post-operatively
total morphine equivalent dose of narcotics
Time frame: 2 weeks and 3 months post-operatively
Presence of neuropathy in the surgical site
Time frame: 2 weeks, 3 months, 6 months and 1 year postoperatively
Incentive Spirometer Volume
Time frame: to discharge (up to 14 days)
Hospital length of stay
Time frame: to discharge (up to 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 41199434Drake L, Weksler B, Specht K, Kuchta P, Crist L, Williams BA, Fernando HC. Cryoanalgesia Increases Neuropathic Pain in Adults Undergoing Minimally Invasive Surgery: A 1-Year Follow-up of a Randomized Study. Ann Surg. 2026 Jun 1;283(6):943-949. doi: 10.1097/SLA.0000000000006973. Epub 2025 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoanalgesia in people with Cryotherapy Effect and Pain, Postoperative, run by Allegheny Singer Research Institute (also known as Allegheny Health Network 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total morphine dose (time frame: to discharge (up to 14 days)). The study lists 2 primary outcomes in all. 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 NCT05348447, which also lists 1 linked publication.
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 13 Feb 2026.