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Cryo Nerve Block Trial
Sponsor: St. Antonius Hospital
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. 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 having minimally invasive lung surgery. Objective: The goal of this study is to determine if ICCA improves recovery compared to the standard pain management after minimally invasive lung surgery. We aim to measure recovery time and quality using the Quality of Recovery 15 (QoR-15) questionnaire. We expect that ICCA will result in better recovery, less pain, less use of opioids, 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 having elective minimally invasive lung resections. Intervention: Patients in the intervention group will receive ICCA in addition to the 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 main outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several areas, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool to measure recovery from surgery. 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 like bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include better recovery, reduced opioid use, less pain, shorter hospital stays, and fewer breathing problems after surgery.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-05-01
Completion Date
2026-12-12
Last Updated
2025-03-06
Healthy Volunteers
No
Interventions
Cryotherapy
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 nerve at the level Th3-Th7. Thus, cryo-analgesia will be applied on 5 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 of between minus 50 and 70 degrees Celsius will be applied.
PAiN - multimodal analgesia
Our standard postoperative pain management plan consists of intercostal nerve block, patient controlled analgesia and acetaminophen
Locations (1)
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands