Cryo Nerve Block Trial

Not Applicable

Not yet recruiting

• Conditions: Intercostal Nerve Block; Cryo Analgesia; Minimally Invasive Lung Surgery
• Interventions: Device: Cryotherapy; Drug: PAiN - multimodal analgesia

• Registration Number: NCT06861387
• Lead Sponsor: St. Antonius Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Study Start: 2025-05-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients are at least 18 years or older.
2. 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.
3. Proficient understanding of the consequences of enrolment by the patients.
4. Written informed consent by the patient.

Exclusion Criteria

1. Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB.
2. Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months).
3. Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol)
4. Patients with connective tissue disease.
5. Patients with comorbidities or history contra-indicating ICCA.
6. Patients who are pregnant.
7. Participation in other clinical trial(s) that may interfere with the current trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryo-analgesia	Cryotherapy	The intervention group will receive intercostal cryo-analgesia and standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.
Cryo-analgesia	PAiN - multimodal analgesia	The intervention group will receive intercostal cryo-analgesia and standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.
Standard care	PAiN - multimodal analgesia	The control group will receive standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.
Registry	Cryotherapy	The registry group will receive intercostal cryo-analgesia and standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen. Patient are eligible for the registry group in case they refuse randomization
Registry	PAiN - multimodal analgesia	The registry group will receive intercostal cryo-analgesia and standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen. Patient are eligible for the registry group in case they refuse randomization

Primary Outcome Measures

Name	Time	Method
Quality of Recovery	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

Secondary Outcome Measures

Name	Time	Method
Pain scores	6 months	In-hospital and outpatient pain scores are based on the numeric rating scale (NRS), whereas score 0 means "no pain" and 10 "extreme pain"
Postoperative opioid consumption	6 months	In-hospital and outpatient postoperative opioid consumption is measured in MME use.
Concomittant analgesia	6 months	use of concomittant analgesia
Postoperative complications	6 months	1. Surgery-related complications.; 2. Surgical site infection.; 3. Respiratory tract infections/pneumonia.; 4. Pneumothorax.; 5. Chest wall hematoma.
Length of stay hospital	6 months	Length of stay hospital
Operative time	6 months	Total operative time

Trial Locations

Locations (1)

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Utrecht, Netherlands