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NCT04224870 · ClinicalTrials.gov registry record
Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 12
- Enrollment target
NCT04224870: Completed study, sponsored by National Institutes of Health Clinical Center (CC).
NCT04224870 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04224870 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
Background: Opioids are a class of drug that are often used to manage pain after a person has surgery. Because of the current opioid crisis, researchers want to improve ways to manage pain after surgery with fewer side effects. To do this, they need to understand pain better. In this study, they want to measure chemical reactions and find genes involved in producing the pain that people feel after surgery. Objective: To find the pain signals starting at the site of skin incision during surgery. Eligibility: People age 18 and older who are having a surgery that will last for at least 4 hours. Design: The participant s primary surgeon will make sure he or she is eligible for surgery. Participants will complete a generalized pain questionnaire before the day of surgery. This will give a baseline measurement. During surgery, 4 to 6 tissue samples at the site of incision will be taken at the following time points: when the surgery starts at 1, 2, 4, and 6 hours when the wound is closed (if the surgery lasts longer than 8 hours). The samples will only be taken if they will not prevent the wound from healing properly. For the first 2 days after surgery, participants will complete short questionnaires about their level of pain. Each will take less than 5 minutes to complete. Their answers will be protected....
Primary Outcome
Quantitative measurements of all expressed transcripts (by RNA-Seq) at each time point collected during surgery (initial incision, 1h, 2h, 4h, 6h, and closure). This will identify the most notable genes according to significance, expression level and fold-change.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2021-03-15 |
What the finished NCT04224870 record still lists
NCT04224870 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04224870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04224870 about?
NCT04224870 is a clinical study titled "Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli". Background: Opioids are a class of drug that are often used to manage pain after a person has surgery. Because of the current opioid crisis, researchers want to improve ways to manage pain after surgery with fewer side effects. To do this, they need to understand pain better. In this study, they wa...
What is the current status of trial NCT04224870?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2020-02-12. Estimated completion is 2021-03-15.
Who is sponsoring clinical trial NCT04224870?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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