Abdominal SurgeryNCT04224870
Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli
An observational study of Abdominal Surgery and Thoracic Surgery, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery, Thoracic Surgery, Urological Surgery
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- Cutaneous incisional tissue sample (removal) is determined by surgeon not to compromise the incisional closure.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- 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.
- Participants with a history of radiation treatment at the incision site, when the incision site was included in the radiation field.
- Participants with other skin conditions that would compromise epidermal and dermal samples in the opinion of the surgeon.
- 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.
- The pain questionnaire will be only available in English, therefore non-English speaking/reading participants are excluded from participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Single Cohort Study 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 want to measure chemical reactions and find genes involved in producing the pain that people feel after surgery.
Read more
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....
Read the 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.
- Conditions
- Abdominal Surgery, Thoracic Surgery, Urological Surgery
- Keywords
- Epidermal, Transcriptomics, Dermal, Surgery, Incision, Natural History
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Incision | A single cohort study, of 12 participants with a scheduled surgical procedure, of at least 4 hours, for up to six (6) timed tissue sampling at surgical incision. No investigational therapy is planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measurements
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.
Measured: end of study
Secondary outcomes (1)
Tandem mass spectrometry (MS/MS)
The endpoint of MS/MS is a quantitative estimate of abundance of the examined molecule (oxylipin or peptide mediators).
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 Feb 2020
- Primary completion7 Nov 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew J Mannes, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224870
- Sponsor's protocol ID
- 200031
- Other IDs
- 20-CC-0031
- Status last verified
- 2 Mar 2026
- First submitted
- 9 Jan 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oberkrom K, Braden K, Li E, Shah SR, Maric D, Mannes AJ, Pacifico P, Jayaraj ND, Arnatt CK, Menichella D, Sapio MR, Salvemini D. Targeting GPR183 to reduce peripheral sensitization: evidence from rodent and human tissue analyses. Pain. 2026 Oct 19. doi: 10.1097/j.pain.0000000000004124. Online ahead of print.
PubMed 42899334
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Cohort Study Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli.
- ClinicalTrials.gov ID
- NCT04224870
- Acronym / sponsor ID
- 200031
- Conditions
- Abdominal Surgery, Thoracic Surgery, Urological Surgery
- Keywords
- Epidermal, Transcriptomics, Dermal, Surgery, Incision, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Incision | – | –A single cohort study, of 12 participants with a scheduled surgical procedure, of at least 4 hours, for up to six (6) timed tissue sampling at surgical incision. No investigational therapy is planned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- Cutaneous incisional tissue sample (removal) is determined by surgeon not to compromise the incisional closure.
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- 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.
- Participants with a history of radiation treatment at the incision site, when the incision site was included in the radiation field.
- Participants with other skin conditions that would compromise epidermal and dermal samples in the opinion of the surgeon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative measurements
Time frame: 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.
1 secondary outcome
Tandem mass spectrometry (MS/MS)
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Derived from this study: PubMed 42899334Oberkrom K, Braden K, Li E, Shah SR, Maric D, Mannes AJ, Pacifico P, Jayaraj ND, Arnatt CK, Menichella D, Sapio MR, Salvemini D. Targeting GPR183 to reduce peripheral sensitization: evidence from rodent and human tissue analyses. Pain. 2026 Oct 19. doi: 10.1097/j.pain.0000000000004124. Online ahead of print.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Mannes, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery and Thoracic Surgery, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measurements (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.