Post Operative PainNCT06639438
Sensory Outcomes in Active Substance Users
An observational study of Post Operative Pain and Opioid Use, Unspecified, run by Boston Medical Center at 1 site in United States.
Trial summary
The incidence and severity of postoperative pain after spine surgery are notably high, often requiring intensive management and potentially affecting the patient's recovery, satisfaction, and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Opioid Use, Unspecified
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects with elective spine procedures scheduled involving incision (including laminectomy, discectomy, foraminotomy, scoliosis correction, decompression and fusion) will be divided into four groups: two no opiod use groups and two opioid use groups. The no opioid use groups will consist of two subgroups of participants with no prior pain disorders who have received no long-term opioid prescriptions (n=10), as well as patients with chronic pain disorders who have received no long-term high dose opioid prescriptions (n=10). The opioid use group will consist of two subgroups- participants with OUD (n=10), and participants without OUD, but have been prescribed opioid medication for chronic pain disorders (n=10).
Who may be able to join
- Opioid user cohorts:
- Individuals with current OUD as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Individuals requiring ≥20 mg of MME/day medication to manage a chronic pain problem.
- Patients scheduled to undergo elective surgery
- Able to provide informed consent
- Control Group Cohorts:
Show all 10Show fewer
- Individuals who are not taking high dose opioids (≤20 MME/day) nor illicit substances and have no history of opioid use disorder
- Individuals with reported chronic pain not yet taking medication for their pain
- Patients scheduled to undergo elective surgery
- Able to provide informed consent
Who cannot join
- Substance User Cohort:
- Patients with contraindications for elective surgery
- Individuals with no history of opioid use
- Control Group Cohort:
- Individuals with a history of opioid use >20 MME/day or illicit substance use
- Patients with contraindications for elective surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center/Boston University Medical Campus
Boston, Massachusetts, 02118
Ala Nozari, MD PhD, 617-638-6950, ala.nozari@bmc.org
Xuan A He, PhD, 617-638-6950, xuan.he@bmc.org
About this study
Official title: Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
The incidence and severity of postoperative pain after spine surgery are notably high, often requiring intensive management and potentially affecting the patient's recovery, satisfaction, and long-term outcomes. Post-operative pain is particularly difficult to manage in patients with substance use disorder likely due to a combination of withdrawal symptoms and molecular changes in the pain matrix. Opiates are the leading cause of overdose related fatalities, and carry a significant burden of substance related morbidity and mortality. As over 80% of patients undergoing low-risk surgery receive opioid prescriptions, the investigators aim to identify unique molecular characteristics of pain within current and previous opioid users, which have been understudied in this context. This study also seeks to understand the molecular mechanisms underlying worsened postoperative pain in patients with opioid use disorder (OUD).
Flow cytometry analysis of human serum will be done, which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation. Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing, focusing on the interplay between nerve endings, resident immune cells, and supporting dermal cells, all of which collectively contribute to the sensation pain. Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participant's postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain.
Read the detailed description
The objective for this research are:
- Assess differences in pain reception in patients with existing or previous opioid use disorder versus controls after elective spine surgery via pain questionnaires at multiple time points during the perioperative care.
- Assess circulating immune signatures and neuropeptides associated with pain signaling before and after surgery in patients with and without OUD using flow cytometry and ELISA of patient serum.
- Assess molecular signatures of dermal cells and nerve endings patients with and without OUD using spatial transcriptomics on epidermis- and dermis-containing tissue samples from surgical incision.
- Conditions
- Post Operative Pain, Opioid Use, Unspecified
- Keywords
- Opioid use disorder (OUD), Gene expression, Visium slide sequencing, Inflammatory profile, Sensation pain, Flow cytometry
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders
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 |
|---|---|---|
| Group 1- Patients with Opioid Use Disorder (OUD) | Participants in this group will be diagnosed with OUD, defined by cognitive, behavioral, and physiological symptoms indicating using opioids despite significant opioid-related problems. | |
| Group 2- Patients who are engaged in long-term opioid therapy (LTOT) for chronic pain | Participants in this group will be engaged in long-term opioid therapy (LTOT) for chronic pain management under medical supervision, without exhibiting the problematic behaviors or experiencing the significant impairment or distress outlined in the OUD criteria. | |
| Group 3- Patients with chronic pain but no (or minimal) opioid use | Participants in this group will have chronic pain but no (or minimal) opioid use where chronic pain is defined as pain that lasts more than three months or beyond the expected period of healing but opioid use is < 20MME with <3 weeks of duration. | |
| Group 4- Patients without chronic pain | Participants in this group will not suffer from chronic pain but choose to undergo spine surgery due to structural abnormalities or conditions that could potentially lead to pain, neurological issues, or other significant health problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific gene expressed
This outcome will be assessed by the transcriptomic profile of dermal tissue from patient excision site using the Visium system to quantify gene expression changes in the dermis. Dermis tissue, about 5mm (length) x 3mm (width) x 2 mm (depth) in size, will be extracted.
Measured: The date of scheduled surgery assessed through the study completion, about two years
Type and concentration of inflammatory cells present and selective biomarkers
The inflammatory profile of whole blood such as the quantity and type of circulating immune cells, e.g. complete blood count (CBC) with differential will be assessed using flow cytometry.A blood sample, about 10mL in volume, will be obtained at the preoperative waiting area immediately after IV placement.
Measured: The date of scheduled surgery assessed through the study completion, about two years
Secondary outcomes (6)
Perceived pain using a visual pain scale
standard Wong-Baker FACES® Pain Rating Scale of 0-10, 0 being no pain, 10 being worst pain
Measured: ~2 weeks before surgery; 24, 36, 48, and 72 hours post-surgery before discharge; ~2 weeks after discharge
Perceived pain using the McGill pain scale
The McGill Pain Questionnaire (MPQ) is composed of 78 words. Respondents choose those that best describe their experience of pain.The McGill pain scale descriptors fall into four groups: sensory, affective, evaluative, and miscellaneous. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Measured: ~2 weeks before surgery; 24 hours post-surgery before discharge; ~2 weeks after discharge
Anesthesia and pain management method
Anesthesia method will be abstracted from the electronic medical records.
Measured: Within 1 week of the surgical visit
Opioid burden
The total amount of analgesics administered will be abstracted from the electronic medical records.
Measured: Within 1 week of the surgical visit
Post-operative recovery and complications
Incision site healing status, infection, and any complications will be abstracted from the electronic medical records.
Measured: Within 1 week of the surgical visit
Perceived pain during postsurgical recovery using the remote pain survey.
Investigator-developed pain survey that describes the pain level, location, and how it affects quality of life. The survey contains a pain scale from 0 to 10 with 0 being no pain and 10 being worst pain. The survey also contains non-numerical measures describing the location and impact of the pain.
Measured: 1, 2, 3, 4 week post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ala Nozari, MD PhD, Principal investigator, Boston Medical Center, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639438
- Sponsor's protocol ID
- H-44193
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
- ClinicalTrials.gov ID
- NCT06639438
- Acronym / sponsor ID
- H-44193
- Conditions
- Post Operative Pain, Opioid Use, Unspecified
- Keywords
- Opioid use disorder (OUD), Gene expression, Visium slide sequencing, Inflammatory profile, Sensation pain, Flow cytometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
The incidence and severity of postoperative pain after spine surgery are notably high, often requiring intensive management and potentially affecting the patient's recovery, satisfaction, and long-term outcomes. Post-operative pain is particularly difficult to manage in patients with substance use disorder likely due to a combination of withdrawal symptoms and molecular changes in the pain matrix. Opiates are the leading cause of overdose related fatalities, and carry a significant burden of substance related morbidity and mortality. As over 80% of patients undergoing low-risk surgery receive opioid prescriptions, the investigators aim to identify unique molecular characteristics of pain within current and previous opioid users, which have been understudied in this context. This study also seeks to understand the molecular mechanisms underlying worsened postoperative pain in patients with opioid use disorder (OUD).
Flow cytometry analysis of human serum will be done, which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation. Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing, focusing on the interplay between nerve endings, resident immune cells, and supporting dermal cells, all of which collectively contribute to the sensation pain. Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participant's postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain.
Detailed description
The objective for this research are:
- Assess differences in pain reception in patients with existing or previous opioid use disorder versus controls after elective spine surgery via pain questionnaires at multiple time points during the perioperative care.
- Assess circulating immune signatures and neuropeptides associated with pain signaling before and after surgery in patients with and without OUD using flow cytometry and ELISA of patient serum.
- Assess molecular signatures of dermal cells and nerve endings patients with and without OUD using spatial transcriptomics on epidermis- and dermis-containing tissue samples from surgical incision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- Patients with Opioid Use Disorder (OUD) | – | –Participants in this group will be diagnosed with OUD, defined by cognitive, behavioral, and physiological symptoms indicating using opioids despite significant opioid-related problems. |
| Group 2- Patients who are engaged in long-term opioid therapy (LTOT) for chronic pain | – | –Participants in this group will be engaged in long-term opioid therapy (LTOT) for chronic pain management under medical supervision, without exhibiting the problematic behaviors or experiencing the significant impairment or distress outlined in the OUD criteria. |
| Group 3- Patients with chronic pain but no (or minimal) opioid use | – | –Participants in this group will have chronic pain but no (or minimal) opioid use where chronic pain is defined as pain that lasts more than three months or beyond the expected period of healing but opioid use is < 20MME with <3 weeks of duration. |
| Group 4- Patients without chronic pain | – | –Participants in this group will not suffer from chronic pain but choose to undergo spine surgery due to structural abnormalities or conditions that could potentially lead to pain, neurological issues, or other significant health problems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with elective spine procedures scheduled involving incision (including laminectomy, discectomy, foraminotomy, scoliosis correction, decompression and fusion) will be divided into four groups: two no opiod use groups and two opioid use groups. The no opioid use groups will consist of two subgroups of participants with no prior pain disorders who have received no long-term opioid prescriptions (n=10), as well as patients with chronic pain disorders who have received no long-term high dose opioid prescriptions (n=10). The opioid use group will consist of two subgroups- participants with OUD (n=10), and participants without OUD, but have been prescribed opioid medication for chronic pain disorders (n=10).
Key inclusion criteria (10 listed)
- Individuals with current OUD as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Individuals requiring ≥20 mg of MME/day medication to manage a chronic pain problem.
- Patients scheduled to undergo elective surgery
- Able to provide informed consent
- Individuals who are not taking high dose opioids (≤20 MME/day) nor illicit substances and have no history of opioid use disorder
Key exclusion criteria (6 listed)
- Patients with contraindications for elective surgery
- Individuals with no history of opioid use
- Individuals with a history of opioid use >20 MME/day or illicit substance use
- Patients with contraindications for elective surgery.
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
Specific gene expressed
Time frame: The date of scheduled surgery assessed through the study completion, about two years
This outcome will be assessed by the transcriptomic profile of dermal tissue from patient excision site using the Visium system to quantify gene expression changes in the dermis. Dermis tissue, about 5mm (length) x 3mm (width) x 2 mm (depth) in size, will be extracted.
Type and concentration of inflammatory cells present and selective biomarkers
Time frame: The date of scheduled surgery assessed through the study completion, about two years
The inflammatory profile of whole blood such as the quantity and type of circulating immune cells, e.g. complete blood count (CBC) with differential will be assessed using flow cytometry.A blood sample, about 10mL in volume, will be obtained at the preoperative waiting area immediately after IV placement.
6 secondary outcomes
Perceived pain using a visual pain scale
Time frame: ~2 weeks before surgery; 24, 36, 48, and 72 hours post-surgery before discharge; ~2 weeks after discharge
Perceived pain using the McGill pain scale
Time frame: ~2 weeks before surgery; 24 hours post-surgery before discharge; ~2 weeks after discharge
Anesthesia and pain management method
Time frame: Within 1 week of the surgical visit
Opioid burden
Time frame: Within 1 week of the surgical visit
Post-operative recovery and complications
Time frame: Within 1 week of the surgical visit
Perceived pain during postsurgical recovery using the remote pain survey.
Time frame: 1, 2, 3, 4 week post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ala Nozari, MD PhD principal investigator
Boston Medical Center, Anesthesiology
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 Post Operative Pain and Opioid Use, Unspecified, run by Boston Medical Center 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ala Nozari, MD PhD (617-638-6950, ala.nozari@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific gene expressed (time frame: The date of scheduled surgery assessed through the study completion, about two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.