Intercostal Nerve BlockNCT06861387
Cryo Nerve Block Trial
A study testing Cryotherapy and PAiN - multimodal analgesia in people with Intercostal Nerve Block and Cryo Analgesia, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Background: Minimally invasive lung surgery, such as video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS), has become more common for lung resections because it leads to faster recovery, less pain, and shorter hospital stays. However, pain after surgery remains a major issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intercostal Nerve Block, Cryo Analgesia, Minimally Invasive Lung Surgery
- What is being tested?
- Cryotherapy and PAiN - multimodal analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2026to 12 Dec 2029
- 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 are at least 18 years or older.
- Patients are electively scheduled to undergo minimally invasive (i.e., VATS or RATS) anatomical lung (i.e., pneumonectomy, (bi)lobectomy, or segmentectomy) resection for benign or malignant disease.
- Proficient understanding of the consequences of enrolment by the patients.
- Written informed consent by the patient.
Who cannot join
- Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB.
- Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months).
- Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol)
- Patients with connective tissue disease.
- Patients with comorbidities or history contra-indicating ICCA.
- Patients who are pregnant.
- Participation in other clinical trial(s) that may interfere with the current trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein, Utrecht
Bart Köhlen, b.kohlen@antoniusziekenhuis.nl
About this study
Official title: A Randomized Controlled Trial Studying the Effect of Additional Intercostal Cryo-analgesia (ICCA) to Standard Postoperative Pain Management in Patients Undergoing Minimally Invasive Lung Surgery
Background:
Minimally invasive lung surgery, such as video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS), has become more common for lung resections because it leads to faster recovery, less pain, and shorter hospital stays. However, pain after surgery remains a major issue. Current guidelines suggest using a combination of pain management strategies to reduce the use of opioids and their side effects. Intercostal cryo-analgesia (ICCA), a technique that uses cold to reduce nerve activity, may help lower pain and opioid use after surgery. However, there is limited research on ICCA, with most studies having small sample sizes and lacking randomized controlled trials. More research is needed to compare ICCA with standard pain management in patients undergoing minimally invasive lung surgery.
Read more
Objective:
The goal of this study is to determine whether ICCA improves recovery compared to standard pain management after minimally invasive lung surgery. The investigators aim to measure recovery time and quality using the Quality of Recovery-15 (QoR-15) questionnaire. The investigators expect that ICCA will result in better recovery, less pain, reduced opioid use, and shorter hospital stays, without increasing the risk of nerve damage or other complications.
Study Design:
This will be a single-center, blinded, randomized controlled trial, along with an observational registry.
Study Population:
The study will include adults who are undergoing elective minimally invasive lung resections.
Intervention:
Patients in the intervention group will receive ICCA in addition to standard pain management after surgery. ICCA will be administered by the surgeon before closing the wound, targeting the intercostal nerves between ribs 3 and 7.
Main Study Parameters/Endpoints:
The primary outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several domains, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool for measuring postoperative recovery.
Risks and Benefits:
This trial will examine the effects of adding ICCA to the standard pain management protocol. Potential risks include numbness or nerve damage, neuropathic pain (pain caused by nerve injury), or complications such as bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include improved recovery, reduced opioid use, less pain, shorter hospital stays, and fewer respiratory complications after surgery.
- Being tested
- Cryotherapy, PAiN - multimodal analgesia
- Keywords
- cryo analgesia, intercostal nerve block, minimally invasive lung surgery, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
AtriCure's cryoICE cryoSPHERE probe will be inserted through one of the incisions used for VATS/RATS. Cryo-analgesia will be performed unilaterally on the intercostal nerves at levels T3-T7. Thus, cryo-analgesia will be applied at five intercostal levels. The probe will be placed at the inferior aspect of the ribs, posterior to the mid-axillary line, directly on the neurovascular bundle. One freezing cycle takes approximately 2 minutes, and a temperature between -50°C and -70°C will be applied.
PAiN - multimodal analgesiaDrug
Our standard postoperative pain management plan consists of intercostal nerve block, patient-controlled analgesia and acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Cryo-analgesia | Experimental | The intervention group will receive intercostal cryo-analgesia in addition to standard postoperative pain management, including intercostal nerve block, patient-controlled analgesia, and acetaminophen. Receives: Device: Cryotherapy; Drug: PAiN - multimodal analgesia |
| Standard care | Active comparator | The control group will receive standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen. Receives: Drug: PAiN - multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of Recovery based on the Quality of Recovery (QoR-15) questionnaire, whereas a minimum of 118 points correspondents with a clinically good recovery
Measured: 6 months
Secondary outcomes (6)
Pain scores
In-hospital and outpatient pain scores are based on the numeric rating scale (NRS), whereas score 0 means "no pain" and 10 "extreme pain"
Measured: 6 months
Postoperative opioid consumption
In-hospital and outpatient postoperative opioid consumption is measured in MME use.
Measured: 6 months
Concomittant analgesia
use of concomittant analgesia
Measured: 6 months
Postoperative complications
- Surgery-related complications.
- Surgical site infection.
- Respiratory tract infections/pneumonia.
- Pneumothorax.
- Chest wall hematoma.
Measured: 6 months
Length of stay hospital
Length of stay hospital
Measured: 6 months
Operative time
Total operative time
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intercostal Nerve BlockStudies 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
- Model description
- Single centre, blinded randomized controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B.T.G. Köhlen, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861387
- Sponsor's protocol ID
- NL88359.100.24
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Studying the Effect of Additional Intercostal Cryo-analgesia (ICCA) to Standard Postoperative Pain Management in Patients Undergoing Minimally Invasive Lung Surgery
- ClinicalTrials.gov ID
- NCT06861387
- Acronym / sponsor ID
- NL88359.100.24
- Keywords
- cryo analgesia, intercostal nerve block, minimally invasive lung surgery, pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 6 Mar 2025 (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.
Background:
Minimally invasive lung surgery, such as video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS), has become more common for lung resections because it leads to faster recovery, less pain, and shorter hospital stays. However, pain after surgery remains a major issue. Current guidelines suggest using a combination of pain management strategies to reduce the use of opioids and their side effects. Intercostal cryo-analgesia (ICCA), a technique that uses cold to reduce nerve activity, may help lower pain and opioid use after surgery. However, there is limited research on ICCA, with most studies having small sample sizes and lacking randomized controlled trials. More research is needed to compare ICCA with standard pain management in patients undergoing minimally invasive lung surgery.
Objective:
The goal of this study is to determine whether ICCA improves recovery compared to standard pain management after minimally invasive lung surgery. The investigators aim to measure recovery time and quality using the Quality of Recovery-15 (QoR-15) questionnaire. The investigators expect that ICCA will result in better recovery, less pain, reduced opioid use, and shorter hospital stays, without increasing the risk of nerve damage or other complications.
Study Design:
This will be a single-center, blinded, randomized controlled trial, along with an observational registry.
Study Population:
The study will include adults who are undergoing elective minimally invasive lung resections.
Intervention:
Patients in the intervention group will receive ICCA in addition to standard pain management after surgery. ICCA will be administered by the surgeon before closing the wound, targeting the intercostal nerves between ribs 3 and 7.
Main Study Parameters/Endpoints:
The primary outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several domains, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool for measuring postoperative recovery.
Risks and Benefits:
This trial will examine the effects of adding ICCA to the standard pain management protocol. Potential risks include numbness or nerve damage, neuropathic pain (pain caused by nerve injury), or complications such as bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include improved recovery, reduced opioid use, less pain, shorter hospital stays, and fewer respiratory complications after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single centre, blinded randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Cryo-analgesia | Experimental | Device: Cryotherapy, Drug: PAiN - multimodal analgesiaThe intervention group will receive intercostal cryo-analgesia in addition to standard postoperative pain management, including intercostal nerve block, patient-controlled analgesia, and acetaminophen. |
| Standard care | Active comparator | Drug: PAiN - multimodal analgesiaThe control group will receive standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are at least 18 years or older.
- Patients are electively scheduled to undergo minimally invasive (i.e., VATS or RATS) anatomical lung (i.e., pneumonectomy, (bi)lobectomy, or segmentectomy) resection for benign or malignant disease.
- Proficient understanding of the consequences of enrolment by the patients.
- Written informed consent by the patient.
Key exclusion criteria (7 listed)
- Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB.
- Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months).
- Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol)
- Patients with connective tissue disease.
- Patients with comorbidities or history contra-indicating ICCA.
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 |
|---|---|---|
| CryotherapyAtriCure's cryoICE cryoSPHERE probe will be inserted through one of the incisions used for VATS/RATS. Cryo-analgesia will be performed unilaterally on the intercostal nerves at levels T3-T7. Thus, cryo-analgesia will be applied at five intercostal levels. The probe will be placed at the inferior aspect of the ribs, posterior to the mid-axillary line, directly on the neurovascular bundle. One freezing cycle takes approximately 2 minutes, and a temperature between -50°C and -70°C will be applied. | Device | Cryo-analgesia |
| PAiN - multimodal analgesiaOur standard postoperative pain management plan consists of intercostal nerve block, patient-controlled analgesia and acetaminophen | Drug | Cryo-analgesia, Standard care |
Primary outcome
Quality of Recovery
Time frame: 6 months
Quality of Recovery based on the Quality of Recovery (QoR-15) questionnaire, whereas a minimum of 118 points correspondents with a clinically good recovery
6 secondary outcomes
Pain scores
Time frame: 6 months
Postoperative opioid consumption
Time frame: 6 months
Concomittant analgesia
Time frame: 6 months
Postoperative complications
Time frame: 6 months
Length of stay hospital
Time frame: 6 months
Operative time
Time frame: 6 months
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 26 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and PAiN - multimodal analgesia in people with Intercostal Nerve Block and Cryo Analgesia, run by St. Antonius Hospital at 1 site in Netherlands.
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: looking for participants now, as of the sponsor's last update on 26 Jun 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 Netherlands. 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?
Contact Bart Köhlen (+31 88 320 1108, b.kohlen@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.