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Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli

NCT04224870 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2026-03-04

No results posted yet for this 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....

Conditions

  • Abdominal Surgery
  • Thoracic Surgery
  • Urological Surgery

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Andrew J Mannes, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2020-11-07
Completion
2021-03-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224870 on ClinicalTrials.gov