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

Completed

• Conditions: Thoracic Surgery; Abdominal Surgery; Urological Surgery

• Registration Number: NCT04224870
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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....

Detailed Description

Background:

* Opioids are the cornerstone of postoperative pain management. However, in light of the current opioid crisis, there is a recognized need for improved postoperative pain management to address pain with fewer side effects.

* New pain medications that are as effective and less problematic are a goal but much of the foundational knowledge required to meet these need is underdeveloped in human studies and are derived from rodent studies.

* We propose to identify critical human tissue nociceptive signals originating at the site of surgical incision initiating the pain response to identify biomarkers of human cutaneous pain signaling.

* Mechanisms of pain and pain sensitivities originating at the surgical site are not well understood.

* Clinical and basic research can unlock the etiology of surgical incisional pain and direct biomedicine to better address this area of underdeveloped research both now and in the future; uniquely providing opportunities to perform important studies on gene expression.

Objectives:

* Identification of transcriptional alterations in epidermal and dermal tissue of at least four (4), but up to six (6) time points during surgical procedures.

* Tandem mass spectrometry (MS/MS) measurement from human epidermal sample to identify alterations in candidate oxylipins and peptide mediators of pain, inflammation and itch.

Eligibility:

-Male or female, aged 18 years and older that are consented for a primary surgical procedure of greater than four (4) hours. Participants without skin abnormalities at tissue sampling site.

Design:

-A single cohort study, of 12 surgical participants with a scheduled surgical procedure, of at least 4 hours, at the NIH Clinical Center, for up to six (6) timed tissue sampling at surgical incision. No investigational therapy is planned.

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-02-12
• Primary Completion: 2020-11-07
• Study Completion: 2021-03-15
• Status Verified: 2025-04-17
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative measurements	end of study	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.

Secondary Outcome Measures

Name	Time	Method
Tandem mass spectrometry (MS/MS)	end of study	The endpoint of MS/MS is a quantitative estimate of abundance of the examined molecule (oxylipin or peptide mediators).

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States