Health TrialsbyHealthPanel

Intercostal Cryoanalgesia in Double Lung Transplant Recipients

ConditionPost-operative Pain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

This study is testing a new way to help manage pain after a double lung transplant. Instead of relying only on strong pain medicines like opioids, doctors will use a cold-therapy probe during surgery to help numb the nerves near the incision. Researchers want to see if this method can reduce the need for opioids and improve recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years of age

Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision

Disqualifiers

Multi-organ transplant recipients

Redo lung transplant recipients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atricure CryoSPHERE MAX Probe

    Device

    Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2 intercostal spaces above and below the thoracotomy incision for 1 minutes for each application during their double lung transplant procedure.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total opioid use (oral morphine equivalents)

Total opioid use (oral morphine equivalents)

Time frame
1 year

Secondary outcomes

1

Frequency of rescue therapy

Compare need for thoracic epidural anesthesia.

Time frame
1 year
2

Median daily pain score

To compare the Median daily pain score for the first 10 days after lung transplantation, Numerical Rating Scale (NRS) (0-10): A standard 11-point scale (0=no pain, 10=worst imaginable pain) used for pain intensity, showing good reliability and validity in various conditions like neuropathic pain.

Time frame
Day 10
3

Duration of ICU Stay

To compare the duration of the ICU stay

Time frame
Days 1-10, 30 days, 60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

AtriCure, Inc.

Collaborator

Source ClinicalTrials.gov
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