An interventional study of Cryotherapy and PAiN - multimodal analgesia in Intercostal Nerve Block, Cryo Analgesia and Minimally Invasive Lung Surgery, sponsored by St. Antonius Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by St. Antonius Hospital · Not applicable, Interventional, and Treatment
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.
St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will receive intercostal cryo-analgesia in addition to standard postoperative pain management, including intercostal nerve block, patient-controlled analgesia, and acetaminophen.
Device: Cryotherapy · Drug: PAiN - multimodal analgesia
The control group will receive standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.
Drug: PAiN - multimodal analgesia
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.
Our standard postoperative pain management plan consists of intercostal nerve block, patient-controlled analgesia and acetaminophen
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
Time frame: 6 months
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"
Time frame: 6 months
Postoperative opioid consumption
In-hospital and outpatient postoperative opioid consumption is measured in MME use.
Time frame: 6 months
Concomittant analgesia
use of concomittant analgesia
Time frame: 6 months
Postoperative complications
1. Surgery-related complications. 2. Surgical site infection. 3. Respiratory tract infections/pneumonia. 4. Pneumothorax. 5. Chest wall hematoma.
Time frame: 6 months
Length of stay hospital
Length of stay hospital
Time frame: 6 months
Operative time
Total operative time
Time frame: 6 months
Presence of neuropathic pain or other sensory changes
hypesthesia, hyperesthesia and/or allodynia
Time frame: 6 months
Prolonged analgesia
Prolonged analgesia more than 3 months after the surgery
Time frame: 6 months
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Agnosia
St. Antonius Hospital