NCT03917823 is a NA clinical trial of Cryoneurolysis in Rib Fractures, sponsored by University of California, San Diego.

Who is sponsoring NCT03917823?

NCT03917823 is sponsored by University of California, San Diego.

What drugs are being tested in NCT03917823?

Interventions in NCT03917823: Cryoneurolysis, Sham comparator.

What condition does NCT03917823 study?

NCT03917823 studies Rib Fractures.

Is NCT03917823 still recruiting?

NCT03917823 is currently terminated. Last updated 11 March 2021.

Are results published for NCT03917823?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-11 · How we verify

NCT03917823

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intercostal Cryoneurolysis Following Traumatic Rib Fractures

Terminated NA Results posted Last updated 11 March 2021

What this trial tests

NA trial testing Cryoneurolysis in Rib Fractures in 4 participants. Terminated before completion.

Timeline

20 April 2019

Primary endpoint
24 September 2019

25 March 2020

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	20 April 2019
Primary completion	24 September 2019
Estimated completion	25 March 2020
Sites	1 location across United States

Drugs / interventions tested

Cryoneurolysis
Sham comparator

Conditions studied

Rib Fractures — all drugs for Rib Fractures →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Rib Fractures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Resting Pain Score Primary · Day following treatment

Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

Group	Value	95% CI
Cryoneurolysis (Active)	5.0	± 2.8
Sham	8.3	± 1.8

Average Pain Score Secondary · Days 2-4, Weeks 1-3, Months 1,3,6

Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

Day 2

Group	Value	95% CI
Cryoneurolysis (Active)	1.5	± 2.1
Sham	8.3	± 0.4

Day 3

Group	Value	95% CI
Cryoneurolysis (Active)	3.5	± 4.9
Sham	8.5	± 0

Day 4

Group	Value	95% CI
Cryoneurolysis (Active)	1.5	± 2.1
Sham	8.0	± 0

Week 1

Group	Value	95% CI
Cryoneurolysis (Active)	2.0	± 2.8
Sham	8.0	± 0

Week 2

Group	Value	95% CI
Cryoneurolysis (Active)	1.0	± 1.4
Sham	4.5	± 0

Week 3

Group	Value	95% CI
Cryoneurolysis (Active)	1.0	± 1.4
Sham	3.5	± 0

Week 4

Group	Value	95% CI
Cryoneurolysis (Active)	1.0	± 1.4
Sham	4.5	± 0

Month 3

Group	Value	95% CI
Cryoneurolysis (Active)	1.0	± 0
Sham	3.0	± 0

Worst Pain Score Secondary · Days 1-4, weeks 1-4, months 3 & 6

Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

Day 1

Group	Value	95% CI
Cryoneurolysis (Active)	7.5	± 3.5
Sham	9.8	± 0.4

Day 2

Group	Value	95% CI
Cryoneurolysis (Active)	4.0	± 5.7
Sham	9.5	± 0.7

Day 3

Group	Value	95% CI
Cryoneurolysis (Active)	4.3	± 6
Sham	10

Day 4

Group	Value	95% CI
Cryoneurolysis (Active)	3.5	± 4.9
Sham	10

Week 1

Group	Value	95% CI
Cryoneurolysis (Active)	3.3	± 4.6
Sham	10

Week 2

Group	Value	95% CI
Cryoneurolysis (Active)	3.5	± 4.9
Sham	7.5

Week 3

Group	Value	95% CI
Cryoneurolysis (Active)	3.0	± 4.2
Sham	7.0

Week 4

Group	Value	95% CI
Cryoneurolysis (Active)	3.0	± 4.2
Sham	5.0

Opioid Consumption Secondary · Days 1-4, 7, 14, 21, and months 1, 3 and 6

Number of opioid tablets consumed previous 24 hours (oxycodone 5 mg)

Day 1

Group	Value	95% CI
Cryoneurolysis (Active)	5.5	± 6.5
Sham	2.8	± 3.9

Day 2

Group	Value	95% CI
Cryoneurolysis (Active)	0.5	± 0.7
Sham	14.5	± 4.9

Day 3

Group	Value	95% CI
Cryoneurolysis (Active)	1.0	± 1.4
Sham	18	± 10

Day 4

Group	Value	95% CI
Cryoneurolysis (Active)	1.0	± 1.4
Sham	24.0	± 0

Week 1

Group	Value	95% CI
Cryoneurolysis (Active)	2.0	± 2.8
Sham	22.0	± 0

Week 2

Group	Value	95% CI
Cryoneurolysis (Active)	2.0	± 2.8
Sham	10	± 0

Week 3

Group	Value	95% CI
Cryoneurolysis (Active)	1.5	± 2.1
Sham	12.0	± 0

Week 4

Group	Value	95% CI
Cryoneurolysis (Active)	0.5	± 0.7
Sham	0	± 0

Incentive Spirometer Volume Secondary · Days 1-4, 7, 14, and 21

maximum incentive spirometer volume

Day 1

Group	Value	95% CI
Cryoneurolysis (Active)	2625	± 530
Sham	1675	± 1520

Day 2

Group	Value	95% CI
Cryoneurolysis (Active)	2375	± 177
Sham	1575	± 1662

Day 3

Group	Value	95% CI
Cryoneurolysis (Active)	2500	± 354
Sham	500

Day 4

Group	Value	95% CI
Cryoneurolysis (Active)	2875	± 884
Sham	500

Day 7

Group	Value	95% CI
Cryoneurolysis (Active)	2750	± 707
Sham	750

Day 14

Group	Value	95% CI
Cryoneurolysis (Active)	2875	± 884
Sham	1250

Day 21

Group	Value	95% CI
Cryoneurolysis (Active)	2875	± 884
Sham	1250

Sponsor's own description

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this randomized, double-masked, sham-controlled study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Cryoneurolysis

Trials testing the same drug.

NCT07303582 — Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities · Phase 4 · recruiting
NCT06942078 — Cryoneurolysis in Patients Awaiting Total Hip and Knee Arthroplasty · NA · not yet recruiting
NCT06958289 — Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System · NA · not yet recruiting
NCT05840276 — Cryoneurolysis Prior to Total Knee Arthroplasty · NA · active not recruiting
NCT05444361 — Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy · NA · enrolling by invitation

Other recruiting trials for Rib Fractures

Currently open trials in the same condition.

NCT05642026 — INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures · Phase 4 · recruiting
NCT06853002 — Deep Breathing Exercises and Incentive Spirometry After Rib Fracture · NA · recruiting
NCT06347874 — Cryo Rib Fracture Study · Phase 4 · recruiting
NCT06222333 — Breathing Exercise for Rib Fracture · NA · recruiting
NCT06519929 — Analgesic Techniques for Rib Fractures · Phase 4 · active not recruiting

Other University of California, San Diego trials

Trials by the same sponsor.

NCT07342543 — Guided Physical Activity Counseling for Hypertension in Primary Care · NA · not yet recruiting
NCT06505317 — Artificial Intelligence for Early Detection of Peripheral Artery Disease · NA · not yet recruiting
NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03917823 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
Last refreshed: 11 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03917823.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03917823

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Cryoneurolysis

Other recruiting trials for Rib Fractures

Other University of California, San Diego trials

Verify against primary sources