Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06861387

Cryo Nerve Block Trial

Led by St. Antonius Hospital · Updated on 2026-04-27

150

Participants Needed

1

Research Sites

188 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cryo Nerve Block Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients are at least 18 years or older.
  • Patients are electively scheduled to undergo minimally invasive (VATS or RATS) anatomical lung resection for benign or malignant disease.
  • Patients understand the consequences of enrollment.
  • Patients provide written informed consent.
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to anesthetic used for intercostal nerve block.
  • Chronic opioid use unrelated to the surgery for more than 3 months.
  • Liver failure preventing use of acetaminophen.
  • Connective tissue disease.
  • Comorbidities or history that contraindicate ICCA.
  • Pregnancy.
  • Participation in other clinical trials that may interfere with this trial.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Actively Recruiting

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Research Team

B

Bart Köhlen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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