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NCT03578237 · ClinicalTrials.gov registry record · NA
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT03578237: Completed NA study, sponsored by University of California, San Diego.
NCT03578237 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 99 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03578237, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study Summary
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chronic" pain. The objective of the proposed pilot study is to optimize the protocol and collect data to power subsequent, definitive clinical trials. Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain. Hypothesis 1a (primary): The severity of surgically-related pain will be significantly decreased on postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1b: The incidence of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Specific Aim 2: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia improves postoperative functioning. Hypothesis 2a: Following primary unilateral knee and shoulder arthroplasty as well as rotator cuff repair, joint range of motion will be significantly increased within the year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 2b: Following video-assisted thoracoscopic surgery, inspiratory spirometry will be improved within the month following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Primary Outcome
Measured with the 0-10 numeric rating scale as part of the Brief Pain Inventory, with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Interventions
- DEVICE Cryoneurolysis (active)
- DEVICE Sham cryoneurolysis procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2018-08-25 |
| Est. Completion | 2022-11-25 |
| Phase | NA |
What the finished NCT03578237 record still lists
NCT03578237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Cryoneurolysis (active) is the first listed.
NCT03578237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03578237 about?
NCT03578237 is a clinical study titled "Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study". The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chr...
What is the current status of trial NCT03578237?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2018-08-25. Estimated completion is 2022-11-25.
What interventions are being tested in trial NCT03578237?
The interventions under investigation include: Cryoneurolysis (active) (DEVICE), Sham cryoneurolysis procedure (DEVICE).
Who is sponsoring clinical trial NCT03578237?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03578237's enrollment target sits among peer trials
99 920th of 2000 higher than 1,079 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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