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Scientists snip skin during surgery to decode pain

NCT ID NCT04224870

Knowledge-focused Sponsor: National Institutes of Health Clinical Center (CC) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study took small skin samples from 12 adults during long surgeries (over 4 hours) to measure chemical reactions and genes linked to pain. The goal is to better understand how pain starts at the incision site, which could lead to safer pain relief options. Participants also filled out short pain questionnaires after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help researchers develop better pain management strategies with fewer side effects than opioids.
What could go wrong
This is a very small, observational study (12 participants) that only collects tissue samples. It does not test any treatment, so it may not lead to direct patient benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Feb 2020

Finished

Mar 2021

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a tissue procurement research protocol, recruiting twelve (12) adult participants for incision tissue procurement during surgical procedures greater than four (4) hours. Potential participants are surgical candidates referred from various surgical services within the Clinical Research Center (CRC); evaluation and interest in this study will be facilitated by the primary surgeon. Once primary informed consent is obtained, the potential participant will be approached by our research team to discuss the tissue procurement study in further detail, and if interested, will be given a Read Only informed consent document to review. On preoperative admission to the CRC, research team members identified in the protocol as able to obtain consent will visit the participant and review the study. Interested participants will formally sign study consent at this time.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, aged 18 years and older. Participant will be consented for a surgical procedure (primary surgical protocol) anticipated to last longer than 4 hours. 2. Cutaneous incisional tissue sample (removal) is determined by surgeon not to compromise the incisional closure. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Participants with known skin abnormalities (dermatologic /dermatitis conditions): psoriasis, atopic dermatitis, rosacea, cancer melanomas, basal cell as well as benign lesions, tissue burns, infections, hematomas, and contusions) at the surgical site. 2. Participants with pre-existing scar tissue at the incision site and/or a history of surgical procedures at the same site. Pre-existing scar tissue will confound the results since the baseline is different from normal non-scar tissue and therefore cannot be used as a basis for comparison. 3. Participants with a history of radiation treatment at the incision site, when the incision site was included in the radiation field. 4. Participants with other skin conditions that would compromise epidermal and dermal samples in the opinion of the surgeon. 5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations (within 6 months) that would limit compliance with study requirements. 6. The pain questionnaire will be only available in English, therefore non-English speaking/reading participants are excluded from participating in the study.

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Conditions

The condition(s) this trial relates to.

Surgical Wound

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal surgery Thoracic surgery Urological surgery

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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