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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 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 99 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03578237
The ClinicalTrials.gov registry entry for NCT03578237 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cryoneurolysis (active) is the first listed.
NCT03578237 reports 0 study locations.
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.
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