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Morton Neuroma

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As a Proof of Concept Study, 5 subjects will follow the same protocol, with one cryoanalgesic treatment (iovera°®) with a 6 month clinical follow-up.

iovera°® treatment will be administered via ultrasound guidance to 1-2 branches of the dorsal/digital/proper nerve/s that innervate the Morton's neuroma. The treatment will be completed one time per subject.

Cryoanalgesia (iovera°®)

Kevin M Miller, DPM, FACPM, FFPM

This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.

Hypothesis:

Cryoanalgesia (iovera°®) will provide a safe, effective and feasible tool as a pain medicine modality to offer analgesic pain relief in patients with Morton's Neuroma, thereby introducing a new non-opioid therapeutic option to these patients in need.

Primary Objective:

To define and characterize the analgesic effect following a single cryoanalgesic application to the Dorsal, Digital Proper Nerve/s in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.

Primary Endpoints:

1. The area under the curve of the Numeric Rating Scale (NRS) Pain Intensity Scores; the NRS is a 0 to 10 rating scale with the number "0" indicating "no pain" and the number "10" indicating the "worst possible pain". The NRS is completed by subjects three times per day from Day 0 to 3 months post treatment, then the NRS will be done weekly through 6 months post treatment. 2. The total daily opioid consumption will be evaluated from Day 0 to 6 months post treatment to determine if the cryoanalgesic treatment decreased the subject's daily opioid pain management requirement.

Secondary Objectives:

1. Safety: To define the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to treatment.
2. Efficacy: To assess the cryoanalgesic application as defined by both the subject and physician; to define the impact of treatment related to ambulatory steps pre and post procedure.
3. Feasibility: To characterize and compare the cryoanalgesic treatment process to Standard of Care (SOC) treatment modalities.

Secondary Endpoints:

1. Safety Endpoints: The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the cryoanalgesic application through 6 months post treatment.
2. Efficacy Endpoints: Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. A wrist device will track the subjects daily steps (ambulation) before and after the cryoanalgesic treatment. Tracking the subject's daily steps before and after treatment may offer an objective measure of cryoanalgesic efficacy. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months. These standardized questionnaires describe how satisfied or unsatisfied the subjects and physician are from the cryoanalgesic treatment.
3. Feasibility Endpoints: Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to Standard of Care treatment modalities.

Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma

A Proof-of-Concept Study to Define the Safety, Efficacy and Feasibility of Cryoanalgesia (Iovera°®) for the Treatment of Pain in Subjects With Morton's Neuroma

Numeric Rating Scale (NRS) Pain Intensity Scores completed by subjects three times per day from Day 0 to 3 months post treatment, then NRS weekly through 6 months post treatment. 2. The total daily opioid consumption from Day 0 to 6 months post treatment.

The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the treatment through 6 months post treatment.

Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months.

Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to SOC treatment modalities.

Pacira Pharmaceuticals, Inc

NorthBay Healthcare

Northern California Research Trials, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Pain, Postoperative

Thoracic Neoplasms

Postoperative Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Arrhythmia Agents

Channel Blockers

Anesthetics

Lidocaine

Ropivacaine

Anesthetics, Local

In patients randomized to this Arm, before the induction of general anesthesia, the epidural catheter is placed in the intervertebral space (T4-T5, T5-6 or T6-T7) and used intra and post-operatively for administration of local anesthetics.

In patients randomized to this Arm, after induction of general anesthesia the Erector spinae plane (ESP) block is performed with a catheter introduced and left in place for continuous postoperative infusion of local anesthetics.

In patients randomized to this Arm, after induction of general anesthesia and single lung ventilation the first thoracoscopic surgical access is performed. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access and the active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8.

The epidural catheter is placed while the patient is awake, before the induction of general anesthesia. The intervertebral spaces used for catheter insertion are alternatively T4-T5, T5-6 or T6-T7. After locating the epidural space through the technique of the loss of resistance, a catheter is introduced for about 5 cm and left in place for the administration of drugs into the epidural space. Once the correct functioning of the epidural catheter has been verified with a negative test for cerebrospinal fluid aspiration and a negative bolus test for the onset of signs and symptoms from intrathecal infusion, the catheter is used intraoperatively for administration of local anesthetics in refracted boluses (Lidocaine and Ropivacaine ) at anesthetic dosage and postoperatively for continuous infusion of Ropivacaine 0.15% at 5 mL/h.

Epidural

Erector spinae plane (ESP) block is performed after induction of general anesthesia, with the patient in a lateral decubitus position. With the aid of the ultrasound guide with linear probe, the transverse process of T5 ipsilateral to the site of the operation is identified. With the in-plane technique, the lower fascia of the ESP muscle is hydrodissected through the administration of Ropivacaine 0.5% 3 mg/Kg lean body weight. Subsequently, a catheter is introduced and left in place for continuous postoperative infusion of Ropivacaine 0.2% at 12 mL/h.

ESP block

Cryoanalgesia is performed after the induction of general anesthesia, single lung ventilation and after performing the first thoracoscopic surgical access. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access. The active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8 and kept resting for 4 ½ minutes on each nerve at a temperature of -70°C, under direct thoracoscopic vision, generating an interruption of the sensory functions.

Cryoanalgesia

MARCO MAMMANA, MD, PhD

MARCO MAMMANA, MD,PhD

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.

In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.

Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.

The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.

In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.

Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.

The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.

All patients undergoing anatomical pulmonary resections (lobectomy or segmentectomy) through a thoracoscopic (VATS) approach, and who present the inclusion/exclusion characteristics, will be considered.

The day of surgery, patients are randomized 1:1:1 to receive 3 different pain control techniques: epidural catheter, ESP block or cryoanalgesia.

A standard pain management protocol will be applied to all patient after surgery.

Primary Outcome Measure is the perceived post-operative pain 24 hours after surgery in the 3 groups, evaluated through numeric pain rating scale (NPRS). Other outcome measures are the post-operative pain trend and the patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents).

Pain Control After VATS Anatomical Pulmonary Resections

Pain Control After VATS Anatomical Pulmonary Resections: Randomized Comparison Between Cryoanalgesia, Erector Spinae Plane Block and Epidural Catheter

Perceived post-operative pain 24 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)

Perceived post-operative pain 1,6,12 and 48 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)

patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma	NCT05604144	Morton's Neurom... Pain Management	Cryoanalgesia (...	18 Years -	Northern California Research Trials, Inc.
Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma	NCT05604144	Morton's Neurom... Pain Management	Cryoanalgesia (...	18 Years -	Northern California Research Trials, Inc.
Pain Control After VATS Anatomical Pulmonary Resections	NCT05993273	Lung Cancer Pain, Postopera... Thoracic Neopla...	Epidural ESP block Cryoanalgesia	18 Years -	University Hospital Padova

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