NCT05348447

Brief Summary

This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection. There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

April 15, 2022

Last Update Submit

February 11, 2026

Conditions

Cryotherapy EffectPain, Postoperative

Keywords

pulmonaryresectioncryotherapy

Outcome Measures

Primary Outcomes (2)

  • Total morphine dose

    total milligrams (mg) of morphine received during hospitalization

    to discharge (up to 14 days)

  • Pain control

    Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome

    to discharge (up to 14 days)

Secondary Outcomes (6)

  • pulmonary complications

    through 1 year

  • pain control

    2 weeks and 3 months post-operatively

  • total morphine equivalent dose of narcotics

    2 weeks and 3 months post-operatively

  • Presence of neuropathy in the surgical site

    2 weeks, 3 months, 6 months and 1 year postoperatively

  • Incentive Spirometer Volume

    to discharge (up to 14 days)

  • +1 more secondary outcomes

Study Arms (2)

Cryoanalgesia with standard of care pain control

EXPERIMENTAL

subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery

Device: cryoanalgesiaOther: Standard of Care Pain Control

Standard of care pain control

ACTIVE COMPARATOR

subjects will receive standard of care pain control only

Other: Standard of Care Pain Control

Interventions

cryoanalgesiaDEVICE

intraoperative intercostal nerve freezing for post-operative pain control

Cryoanalgesia with standard of care pain control
Standard of Care Pain ControlOTHER

Standard of Care Pain Control Post-operatively

Cryoanalgesia with standard of care pain controlStandard of care pain control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 year and older.
  • Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
  • Performance status of 1 or 2.

You may not qualify if:

  • Patients with ejection fraction less than 40%
  • Patients with creatinine greater than 1.5.
  • Patients with Child's B or C cirrhosis
  • Patients on chronic narcotics for other reasons
  • Patients diagnosed with fibromyalgia
  • Patients who had previous thoracic surgery on the same side.
  • Patients who cannot communicate in English.
  • Patients unable to provide informed consent for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will be blinded to treatment group and will be sedated (part of standard of care surgery) at the time the treatment occurs
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
System Chief of Thoracic Surgery

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 27, 2022

Study Start

April 21, 2022

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(1)