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Outcome Measures

Primary Outcomes (1)

Maximum Inspired Volume
maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.\[Restrepo. Respirated Care 2011\] The best of three measurements will be recorded as the maximum inspired volume.
Day 1 of study treatment

Secondary Outcomes (8)

Maximum Inspired Volume
Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2
Spirometry Pain
Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2
Brief Pain Inventory (Pain Scale)
Days 1, 2, and 7
Brief Pain Inventory (Interference Scale)
Day 14, and Months 1, 1.5, 2, 3, 6, and 12
Sleep Disturbances Due to Pain
Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12
+3 more secondary outcomes

Study Arms (2)

Cryoneurolysis and placebo intercostal nerve block

ACTIVE COMPARATOR

Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.

Device: Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas)Drug: Placebo intercostal nerve block with normal saline

Sham cryoneurolysis and active intercostal nerve block

SHAM COMPARATOR

Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.

Drug: Intercostal nerve block ropivacaine with epinephrineDevice: Sham cryoneurolysis with a Painblocker

Interventions

Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas)Device

The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.

Cryoneurolysis and placebo intercostal nerve block

Intercostal nerve block ropivacaine with epinephrineDrug

3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry

Intercostal nerve block ropivacaine with epinephrine

The registry names several treatments. This does not confirm that participants received them together or that they form a single product.

View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patients of at least 18 years of age
having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint sustained within the previous 3 days (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR

Masking Details

The randomization lists will be created by the UC San Diego Investigational Drug Service which will create the sealed, opaque randomization envelopes with treatment group assignments. The treating investigators doing the procedures will be the only other individuals aware of the treatment group assignments. The Investigational Drug Service will not provide the treatment group assignments to the investigators until the completion of data collection for all subjects; and will only provide "Treatment A" vs "Treatment B" assignments for the initial statistical analysis. Only at the completion of statistical analysis will each treatment be revealed to the investigators.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Multicenter, randomized, double-masked, sham-controlled, parallel design, clinical trial

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Professor of Anesthesiology, In Residence

Rib Fracture Analgesia Using Cryoanalgesia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Cryoneurolysis and placebo intercostal nerve block

Sham cryoneurolysis and active intercostal nerve block

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Cryoneurolysis and placebo intercostal nerve block

Sham cryoneurolysis and active intercostal nerve block

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations