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.

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.