Postoperative Pain ManagementNCT07099469
Compairing R-ICNB and C-ICNB for Postoperative Pain Management After Minimal-invasive Anatomical Lung Resection
An observational study of Postoperative Pain Management and RATS Surgery, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
This is a pilot study in which a total of 6 people will participate. This study aims to optimize the postoperative pain management of an anatomically minimally invasive lung resection (RATS) by comparing 2 pain-relieving techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management, RATS Surgery
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Mar 2025to 1 Nov 2026
- Phase
- Observational
- 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
Study population: Patients referred for anatomical lung resection (lobectomy or segmentectomy) with the intention of performing it by robotic-assisted thoracoscopic surgery (RATS) are eligible for the trial.
Who may be able to join
- Adult patients of 18 years or older who are able to give informed consent and fill out questionnaires in Dutch.
Who cannot join
- Patients who need an anatomic resection of the lung that's larger than one lung lobe, who have CPAM or infections.
- Patients with chronic use (>3 months) of strong opioids because of co-morbidities -for example, the use of tramadol is allowed.
- If there's a high risk of conversion to a thoracotomy. This will be evaluated by the lung surgeon.
- Patients who have had thoracic surgery in the past.
- Patients with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pilot Study of ICNB With Ropivacaine Versus ICNB With Cryotherapy for Postoperative Pain Management After RATS Anatomical Resection for Lung Cancer.
This is a pilot study in which a total of 6 people will participate. This study aims to optimize the postoperative pain management of an anatomically minimally invasive lung resection (RATS) by comparing 2 pain-relieving techniques. As standard, an intercostal block is placed at the end of the procedure by injecting a local anesthetic at the site where the patient will be operated on. This study compares the previous method with the use of cryotherapy as an intercostal block. This technique uses cryo probes and blocks postoperative pain for 1-3 months. By comparing both techniques, it is examined whether cryotherapy requires less pain medication and is therefore more effective.
Read the detailed description
Adequate pain control after robotic-assisted thoracic surgery (RATS) for lung resection is important to improve postoperative mobilisation and recovery, and to prevent postoperative pulmonary complications.
Thoracic epidural analgesia (TEA) is the usual care for postoperative pain management following thoracic surgery. Although the analgesic effect of TEA is clear, failure rates are 9-30% [1, 2, 3] and awake placement is stressful for patients. In addition, TEA is associated with patient immobilisation, bladder dysfunction and hypotension [4]. Based on the best available evidence and the recent guidelines by the Enhanced Recovery After Surgery (ERAS) society, the European Society of Thoracic Surgeons (ESTS) includes early mobilisation after surgery as one of their key recommendations [5]. The department of Thoracic Surgery of the Antwerp University Hospital (UZA) has developed its own ERAS protocol for minimal-invasive lung surgery. The standard technique for this protocol is single-shot intercostal nerve blockade (ICNB) with ropivacaine.
This study wants to evaluate single-shot ICNB with ropivacaine versus ICNB with cryotherapy. Single-shot peripheral nerve blockade has a risk for increased need for opioids and less patient satisfaction compared to a continuous infusion technique, especially when using a multi-port robotic technique [6]. On the other hand, the technique is good in the majority of cases, easy to perform, low costs compared to the standard TEA care [7] and there is a lower incidence of adverse events [8]. Unilateral regional techniques are not associated with patient immobilisation, bladder dysfunction and hypotension [9]. The ICNB with cryotherapy is a newer technique with the advantage of blocking post-surgical pain for 1 to 3 months, while allowing the axons to regenerate. The risk for additional medication is therefore less. However, the disadvantage is the fact that the probes developed to induce this block are expensive and not refunded in Belgium. For this small randomized pilot study, 3 cryotherapy probes are given for free by the company AtriCure. This offers us the opportunity to study the outcome of ICNB with cryotherapy and ropivacaine (standard technique).
Postoperative pain that is not effectively treated or controlled will lead to chronic pain which is hard to control. Because of this it is really important to have an effective strategy in the first 3 months post-op to reduce chronic pain [10, 11]. With this study the investigators want to compare 2 techniques to see which analgesic single-shot technique meets the patient's satisfaction and it will also determine the most cost-effective pain strategy. When ICNB with cryotherapy seems promising compared to ICNB with ropivacaine in terms of patient satisfaction and pain control, a larger trial can be initiated.
The results of this study will give the investigators a first idea whether ICNB with cryotherapy can offer a clear advantage over ICNB with ropivacaine.
References
- J. Hermanides, M.W. Hollmann, M.F. Stevens, P. Lirk. Failed epidural: causes and management. British Journal of Anaesthesia 109 (2): 144-54 (2012) 2. N. T. Ventham, M. Hughes, S. O'Neill, N. Johns, R. R. Brady and S. J. Wigmore. Systematic review and meta-analysis of continuous local anaesthetic wound infiltration versus epidural analgesia for postoperative pain following abdominal surgery. British Journal of Surgery 2013; 100: 1280-1289 4. A. Clemente, F. Carli. The physiological effects of thoracic epidural anesthesia and analgesia on the cardiovascular, respiratory and gastrointestinal systems. Minerva Anestesiologica 2008; 74: 549-63.
- Timothy J.P. Batchelor, Neil J. Rasburn, Etienne Abdelnour-Berchtold, Alessandro Brunelli, Robert J. Cerfolio, et al. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERASVR) Society and the European Society of Thoracic Surgeons (ESTS). European Journal of Cardio-Thoracic Surgery 55 (2019) 91-115.
- Ann E Bingham , Rochelle Fu, Jean-Louis Horn, Matthew S Abrahams. Continuous peripheral nerve block compared with single-injection peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Reg Anesth Pain Med, Nov-Dec 2012;37(6):583-94.
- Melissa Medina, Shannon R. Foiles, Matilde Francois, Carl V. Asche, Jinma Ren. Comparison of cost and outcomes in patients receiving thoracic epidural versus liposomal bupivacaine for video-assisted thoracoscopic pulmonary resection. The American Journal of Surgery 217 (2019) 520e524.
- Marzia Umari, Stefano Falini, Matteo Segat, Michele Zuliani, Marco Crisman. Anesthesia and fast-track in video-assisted thoracic surgery (VATS): from evidence to practice. J Thorac Dis 2018;10(Suppl 4):S542-S554.
- Alieh Zamani Kiasari, Anahita Babaei, Abbas Alipour, Shima Motevalli, Afshin Gholipour Baradari. Comparison of Hemodynamic Changes in Unilateral Spinal Anesthesia Versus Epidural Anesthesia Below the T10 Sensory Level in Unilateral Surgeries: a Double-Blind Randomized Clinical Trial. Med Arch. 2017 AUG; 71(4): 274-279 10. Blichfeldt-Eckhar M.R., Andersen, C., Ørding, H., Licht, P.B. \& Toft, P. (2018). From acute to chronic pain after thoracic surgery: the significance of different components of the acute pain response. J Pain Res 11:1541-8. doi: 10.2147/JPR.S161303. PMID: 30147358; PMCID: PMC6101742.
- Gan, T.J. (2017). Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res, 10:2287-98. doi:10.2147/JPR.S144066. PMID: 29026331; PMCID: PMC5626380.
- Conditions
- Postoperative Pain Management, RATS Surgery
- Keywords
- C-ICNB, R-ICNB, RATS Surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| R-ICNB | At the end of the procedure, an intercostal block is placed by injecting a local anesthetic into the site of surgery. | |
| C-ICNB | At the end of the surgery single shot cryotherapy will be placed at 6 levels (T3-T8) with the AtriCure"s cryoICE cryosphere cryoablation probes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The NRS pain score
The NRS score will be used to measure pain scores and this will be the primary outcome of the study.
Measured: Baseline, post-operative (day 0) in the recoveryward when the patient is awake and after 6 hours. Day 1-2-3 the NRS wil be measured in the morning, afternoon and evening. During the Follow-up visits: 2 weeks and 12 weeks after surgery
Secondary outcomes (8)
QoR-15 questionnaire
The QoR-15 will provide a continuous variable with a minimum score of 0 and a maximum score of 150 and contains the most relevant questions concerning 5 domains (emotional status, physical comfort, psychological support, physical independence and pain) of overall well-being and recovery after surgery.
Measured: Measured at baseline, post-operative after surgery day 0, day 1, day 2 day 3 and day 4 during hospitalisation. At Folluw-up visit after 2 weeks and after 12 weeks
Lenght of stay
Lenght of stay, defined as the total number of days in hospital after the surgical intervention.
Measured: From date of hospitalization until discharge, estimated time of hospitalisation is 5 days, but we will measure until discharge from the hospital.
Use of pain medication
Cumulative use of systemic opioids and analgesics
Measured: during the postopertieve hospotalization periode, day 0 till day 3
Pain during mobilization
Proportion of postoperative pain scores of NRS >3 during mobilization
Measured: During the postopertieve hospotalization periode, day 0 till day 3
Patient satisfaction
Measured using a likert 5-point scale going from Very unsatisfied to very satisfied.
Measured: During post-opertieve periode day 0 - day 3.
Chest tube days
Time to removal of the chest tube in days;
Measured: During post-opertieve periode day 0 - day 3, while hospilized.
urinary catheter in situ days
Time to removal of urinary catheter in days;
Measured: During post-opertieve periode day 0 - day 3, while hospilized.
Degree of mobility
Degree of mobility (1-4 scale) at POD 1-3:
- on the bed
- to the chair
- to the toilet
- outside the patient's hospital room
At POD 0 the degree of mobility is based on 2 options: patient hasn't been out of bed or went from bed to chair.
Measured: During post-opertieve periode day 0 - day 3, while hospilized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start25 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen Hendriks, University Hospital, Antwerp
- Investigators
- Prof. J. Hendriks, MD. PhD., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099469
- Sponsor's protocol ID
- 004017
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of ICNB With Ropivacaine Versus ICNB With Cryotherapy for Postoperative Pain Management After RATS Anatomical Resection for Lung Cancer.
- ClinicalTrials.gov ID
- NCT07099469
- Acronym / sponsor ID
- 004017
- Conditions
- Postoperative Pain Management, RATS Surgery
- Keywords
- C-ICNB, R-ICNB, RATS Surgery, postoperative pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Aug 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.
This is a pilot study in which a total of 6 people will participate. This study aims to optimize the postoperative pain management of an anatomically minimally invasive lung resection (RATS) by comparing 2 pain-relieving techniques. As standard, an intercostal block is placed at the end of the procedure by injecting a local anesthetic at the site where the patient will be operated on. This study compares the previous method with the use of cryotherapy as an intercostal block. This technique uses cryo probes and blocks postoperative pain for 1-3 months. By comparing both techniques, it is examined whether cryotherapy requires less pain medication and is therefore more effective.
Detailed description
Adequate pain control after robotic-assisted thoracic surgery (RATS) for lung resection is important to improve postoperative mobilisation and recovery, and to prevent postoperative pulmonary complications.
Thoracic epidural analgesia (TEA) is the usual care for postoperative pain management following thoracic surgery. Although the analgesic effect of TEA is clear, failure rates are 9-30% [1, 2, 3] and awake placement is stressful for patients. In addition, TEA is associated with patient immobilisation, bladder dysfunction and hypotension [4]. Based on the best available evidence and the recent guidelines by the Enhanced Recovery After Surgery (ERAS) society, the European Society of Thoracic Surgeons (ESTS) includes early mobilisation after surgery as one of their key recommendations [5]. The department of Thoracic Surgery of the Antwerp University Hospital (UZA) has developed its own ERAS protocol for minimal-invasive lung surgery. The standard technique for this protocol is single-shot intercostal nerve blockade (ICNB) with ropivacaine.
This study wants to evaluate single-shot ICNB with ropivacaine versus ICNB with cryotherapy. Single-shot peripheral nerve blockade has a risk for increased need for opioids and less patient satisfaction compared to a continuous infusion technique, especially when using a multi-port robotic technique [6]. On the other hand, the technique is good in the majority of cases, easy to perform, low costs compared to the standard TEA care [7] and there is a lower incidence of adverse events [8]. Unilateral regional techniques are not associated with patient immobilisation, bladder dysfunction and hypotension [9]. The ICNB with cryotherapy is a newer technique with the advantage of blocking post-surgical pain for 1 to 3 months, while allowing the axons to regenerate. The risk for additional medication is therefore less. However, the disadvantage is the fact that the probes developed to induce this block are expensive and not refunded in Belgium. For this small randomized pilot study, 3 cryotherapy probes are given for free by the company AtriCure. This offers us the opportunity to study the outcome of ICNB with cryotherapy and ropivacaine (standard technique).
Postoperative pain that is not effectively treated or controlled will lead to chronic pain which is hard to control. Because of this it is really important to have an effective strategy in the first 3 months post-op to reduce chronic pain [10, 11]. With this study the investigators want to compare 2 techniques to see which analgesic single-shot technique meets the patient's satisfaction and it will also determine the most cost-effective pain strategy. When ICNB with cryotherapy seems promising compared to ICNB with ropivacaine in terms of patient satisfaction and pain control, a larger trial can be initiated.
The results of this study will give the investigators a first idea whether ICNB with cryotherapy can offer a clear advantage over ICNB with ropivacaine.
References
- J. Hermanides, M.W. Hollmann, M.F. Stevens, P. Lirk. Failed epidural: causes and management. British Journal of Anaesthesia 109 (2): 144-54 (2012) 2. N. T. Ventham, M. Hughes, S. O'Neill, N. Johns, R. R. Brady and S. J. Wigmore. Systematic review and meta-analysis of continuous local anaesthetic wound infiltration versus epidural analgesia for postoperative pain following abdominal surgery. British Journal of Surgery 2013; 100: 1280-1289 4. A. Clemente, F. Carli. The physiological effects of thoracic epidural anesthesia and analgesia on the cardiovascular, respiratory and gastrointestinal systems. Minerva Anestesiologica 2008; 74: 549-63.
- Timothy J.P. Batchelor, Neil J. Rasburn, Etienne Abdelnour-Berchtold, Alessandro Brunelli, Robert J. Cerfolio, et al. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERASVR) Society and the European Society of Thoracic Surgeons (ESTS). European Journal of Cardio-Thoracic Surgery 55 (2019) 91-115.
- Ann E Bingham , Rochelle Fu, Jean-Louis Horn, Matthew S Abrahams. Continuous peripheral nerve block compared with single-injection peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Reg Anesth Pain Med, Nov-Dec 2012;37(6):583-94.
- Melissa Medina, Shannon R. Foiles, Matilde Francois, Carl V. Asche, Jinma Ren. Comparison of cost and outcomes in patients receiving thoracic epidural versus liposomal bupivacaine for video-assisted thoracoscopic pulmonary resection. The American Journal of Surgery 217 (2019) 520e524.
- Marzia Umari, Stefano Falini, Matteo Segat, Michele Zuliani, Marco Crisman. Anesthesia and fast-track in video-assisted thoracic surgery (VATS): from evidence to practice. J Thorac Dis 2018;10(Suppl 4):S542-S554.
- Alieh Zamani Kiasari, Anahita Babaei, Abbas Alipour, Shima Motevalli, Afshin Gholipour Baradari. Comparison of Hemodynamic Changes in Unilateral Spinal Anesthesia Versus Epidural Anesthesia Below the T10 Sensory Level in Unilateral Surgeries: a Double-Blind Randomized Clinical Trial. Med Arch. 2017 AUG; 71(4): 274-279 10. Blichfeldt-Eckhar M.R., Andersen, C., Ørding, H., Licht, P.B. \& Toft, P. (2018). From acute to chronic pain after thoracic surgery: the significance of different components of the acute pain response. J Pain Res 11:1541-8. doi: 10.2147/JPR.S161303. PMID: 30147358; PMCID: PMC6101742.
- Gan, T.J. (2017). Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res, 10:2287-98. doi:10.2147/JPR.S144066. PMID: 29026331; PMCID: PMC5626380.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-ICNB | – | –At the end of the procedure, an intercostal block is placed by injecting a local anesthetic into the site of surgery. |
| C-ICNB | – | –At the end of the surgery single shot cryotherapy will be placed at 6 levels (T3-T8) with the AtriCure"s cryoICE cryosphere cryoablation probes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for anatomical lung resection (lobectomy or segmentectomy) with the intention of performing it by robotic-assisted thoracoscopic surgery (RATS) are eligible for the trial.
Key inclusion criteria (1 listed)
- Adult patients of 18 years or older who are able to give informed consent and fill out questionnaires in Dutch.
Key exclusion criteria (5 listed)
- Patients who need an anatomic resection of the lung that's larger than one lung lobe, who have CPAM or infections.
- Patients with chronic use (>3 months) of strong opioids because of co-morbidities -for example, the use of tramadol is allowed.
- If there's a high risk of conversion to a thoracotomy. This will be evaluated by the lung surgeon.
- Patients who have had thoracic surgery in the past.
- Patients with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The NRS pain score
Time frame: Baseline, post-operative (day 0) in the recoveryward when the patient is awake and after 6 hours. Day 1-2-3 the NRS wil be measured in the morning, afternoon and evening. During the Follow-up visits: 2 weeks and 12 weeks after surgery
The NRS score will be used to measure pain scores and this will be the primary outcome of the study.
8 secondary outcomes
QoR-15 questionnaire
Time frame: Measured at baseline, post-operative after surgery day 0, day 1, day 2 day 3 and day 4 during hospitalisation. At Folluw-up visit after 2 weeks and after 12 weeks
Lenght of stay
Time frame: From date of hospitalization until discharge, estimated time of hospitalisation is 5 days, but we will measure until discharge from the hospital.
Use of pain medication
Time frame: during the postopertieve hospotalization periode, day 0 till day 3
Pain during mobilization
Time frame: During the postopertieve hospotalization periode, day 0 till day 3
Patient satisfaction
Time frame: During post-opertieve periode day 0 - day 3.
Chest tube days
Time frame: During post-opertieve periode day 0 - day 3, while hospilized.
urinary catheter in situ days
Time frame: During post-opertieve periode day 0 - day 3, while hospilized.
Degree of mobility
Time frame: During post-opertieve periode day 0 - day 3, while hospilized.
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 6 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Prof. J. Hendriks, MD. PhD. principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Management and RATS Surgery, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 inclusion and 5 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 6 May 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 Belgium. 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?
The NRS pain score (time frame: Baseline, post-operative (day 0) in the recoveryward when the patient is awake and after 6 hours. Day 1-2-3 the NRS wil be measured in the morning, afternoon and evening. During the Follow-up visits: 2 weeks and 12 weeks after surgery). 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 6 May 2026.