Postsurgical Pain ManagementPhase 3TPS-SelectNCT07296770
An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service
A Phase 3 study testing TPS-Select, Pharmacologic Pain Management and Interventional Pain Procedures in people with Postsurgical Pain Management and Postsurgical Pain, Chronic, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postsurgical Pain Management, Postsurgical Pain, Chronic, Opioid Use After Surgery
- What is being tested?
- TPS-Select, Pharmacologic Pain Management and Interventional Pain Procedures
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2029
- Phase
- Phase 3
- 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
Patients may take part in this study if they:
- Are 18 years or older
- Are having a planned (elective) surgery at UCSF
- Are identified as higher risk for chronic pain after surgery by a computer model
- Agree to join the study and sign consent
Patients cannot take part if they:
- Have too much missing information in their medical record (more than 75%)
- Have a surgery scheduled less than 21 days away
- Have serious memory or thinking problems that make participation difficult
- Are in another clinical study that would interfere with this one
- Do not live in California
- Choose not to participate or sign consent
- Have severe depression with suicidal thoughts that requires urgent care
- Are pregnant or breastfeeding
A patient who has already joined may be removed from the study if they:
- Cannot complete most of the scheduled follow-up phone calls or pre-surgery recommendations (up to 6 months after discharge)
- Pass away between the surgery booking date and 6 months after leaving the hospital
- Become pregnant in the 6 months after discharge
Patients may remain enrolled but their data may not be used in the main study results if they experience:
- A long-lasting infection after surgery
- Hardware problems related to their surgery (for example, issues with implanted devices)
- A major injury or life event that affects their pain levels, such as a significant fall or an emergency surgery
- Difficulty completing the planned follow-up phone calls up to 6 months after discharge
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
UCSF Hospitals
San Francisco, California, 94131
Andrew Bishara, MD, 419-266-4764, andrew.bishara@ucsf.edu
About this study
The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.
- Being tested
- TPS-Select, Pharmacologic Pain Management, Interventional Pain Procedures, Psychological Management and Pain Education, Physical Therapy
- Keywords
- Pain, Transitional Pain Service, Postsurgical Pain, Postoperative Opioid Use
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPS-SelectDevice
TPS-Select is a computer-based tool that helps the research team identify patients who may be eligible for this study. It uses information that already exists in the medical record at the time a surgery is scheduled to estimate the chance of developing ongoing pain after surgery. This information can include details about the planned surgery, prior medical conditions, past surgeries, and previous use of pain medications.
The tool runs automatically and is used only to help the research team decide whom to contact about possible participation in the study. The risk estimate created by this tool is not added to the medical record and is not seen by the patient's care team. Only approved members of the research team can see this information through a secure research system.
Pharmacologic Pain ManagementDrug
Also called Oxycodone Hydrochloride, Hydrocodone Bitartrate and Acetaminophen, Morphine Sulfate, Methadone Hydrochloride
A pharmacist will meet with patients as part of the Transitional Pain Service before and after surgery. During this visit, the pharmacist will work with patients to create a personalized pain management plan, using the medications stated in this intervention to help safely and effectively control pain. This will guide patients on the proper use of opioid analgesics and non-opioid analgesics, including acetaminophen, non-steroid anti-inflammatory drugs, gabapentinoids, and topical medications to manage surgical pain.
Interventional Pain ProceduresProcedure or surgery
Also called Epidural Steroid Injection, Acupuncture, Trigger Point Injection, Peripheral Nerve Block
If a patient has significant pain after their surgery, the care team may evaluate the patient for additional pain-relief options, such as the interventional pain procedures listed above. Local numbing medication or imaging studies may also be used to ensure the treatment is safe and appropriate. All anesthesiologists on the pain service are specially trained to perform these procedures. Only approved procedures will be offered, along with any imaging needed for evaluation.
Psychological Management and Pain EducationBehavioural
Patients will be asked to complete short online pain education modules to help set expectations and prepare for pain after surgery. These materials are available at https://www.transitionalpainservice.ca/learn. Each patient will also be screened for mood-related concerns, including symptoms of depression, using a brief questionnaire. If a patient has significant symptoms of depression, they may be referred to a pain psychologist and, if needed, a UCSF psychiatrist for additional support. These visits may include proven approaches such as cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based strategies to help patients manage pain, cope with stress, and improve daily functioning. Patients with milder symptoms may be referred to group-based pain psychology sessions led by a pain psychologist.
Physical TherapyBehavioural
Patients will be assessed for their physical function and ability to carry out daily activities. If a patient has difficulty with mobility, strength, or endurance, they may be referred to physical or occupational therapy before surgery to help improve overall conditioning. Pre-surgery therapy may include exercises to strengthen the core, arms, and legs, improve balance, and build stamina, as well as an overall fitness assessment. Referrals will only be made if it is safe for the patient to participate, and standard safety checks-such as heart health and fall risk-will be completed beforehand. All therapy will be provided by a licensed physical therapist using established, evidence-based treatment plans.
| Study group | Role | What they receive |
|---|---|---|
| Transitional Pain Service | Experimental | Patients assigned to the Transitional Pain Service group will receive extra support before and after surgery to help with pain and recovery. This may include educational videos, meetings with a pain pharmacist for safe medication use and tapering, mental health screening with referrals to supportive resources, and physical therapy. Patients may also be offered pain-relief procedures or treatments such as nerve blocks, injections, imaging, or other outpatient therapies provided by pain specialists. These services are meant to support recovery, and patients may choose how much to participate while remaining in the study even if all activities are not completed. Receives: Device: TPS-Select; Drug: Pharmacologic Pain Management; Procedure: Interventional Pain Procedures; Behavioral: Psychological Management and Pain Education; Behavioral: Physical Therapy |
| Usual Care | No intervention | In this arm, patients will receive usual surgical care. However, patients will still complete the questionnaires to measure their pain, opioid use, and recovery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Chronic Post-Surgical Pain
This outcome measures how many patients in each group (Standard of Care vs. Transitional Pain Service) have chronic post-surgical pain 90 days after date of surgery. Chronic post-surgical pain refers to worsening pain in a preoperative pain region or the development of pain in a new region.
Measured: 90 days after date of surgery
Secondary outcomes (4)
Opioid Use After Surgery
This measures the amount of opioid medication patients are using after surgery, recorded as morphine milligram equivalents (MMEs). Average MMEs will be compared between groups to see whether the program helps reduce opioid needs.
Measured: 30, 90, and 180 days after discharge from hospital
Pain Levels After Surgery
This outcome looks at patients' reported pain magnitude and pain interference scores over time. The study will compare average pain levels between the two groups to understand how the program affects recovery.
Measured: 30, 90, and 180 days after discharge from the hospital
Healthcare Costs
This measures costs to the hospital related to pain care and recovery after surgery. Average costs will be compared between groups to evaluate whether the Transitional Pain Service may reduce overall costs.
Measured: 30, 90, and 180 days after discharge from the hospital
Pain in Surgical Region
This outcome mreasures patient-reported presence of pain localized to the surgical site.
Measured: 30 Days, 90 Days, 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After a patient joins the study, they will be randomly assigned to either the standard care group or the Transitional Pain Service (TPS) group. The assignment will be done by the study coordinator using a process that helps keep the groups balanced by sex. All patients in the study are considered high-risk.
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Bishara, MD, Principal investigator, UCSF Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296770
- Sponsor's protocol ID
- 24-42631
- Acronym
- TPS-Select
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared with outside researchers because the information collected in this study includes sensitive health details that could pose privacy risks if shared. Although all data are protected and stored securely, sharing IPD outside the study team may increase the chance of re-identification. To protect patient privacy, only summarized results that do not identify any individual will be shared publicly.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service
- ClinicalTrials.gov ID
- NCT07296770
- Acronym / sponsor ID
- TPS-Select / 24-42631
- Keywords
- Pain, Transitional Pain Service, Postsurgical Pain, Postoperative Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 22 Dec 2025 (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 goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After a patient joins the study, they will be randomly assigned to either the standard care group or the Transitional Pain Service (TPS) group. The assignment will be done by the study coordinator using a process that helps keep the groups balanced by sex. All patients in the study are considered high-risk.
| Arm | Type | Receives |
|---|---|---|
| Transitional Pain Service | Experimental | Device: TPS-Select, Drug: Pharmacologic Pain Management, Procedure: Interventional Pain Procedures, Behavioral: Psychological Management and Pain Education, Behavioral: Physical TherapyPatients assigned to the Transitional Pain Service group will receive extra support before and after surgery to help with pain and recovery. This may include educational videos, meetings with a pain pharmacist for safe medication use and tapering, mental health screening with referrals to supportive resources, and physical therapy. Patients may also be offered pain-relief procedures or treatments such as nerve blocks, injections, imaging, or other outpatient therapies provided by pain specialists. These services are meant to support recovery, and patients may choose how much to participate while remaining in the study even if all activities are not completed. |
| Usual Care | No intervention | –In this arm, patients will receive usual surgical care. However, patients will still complete the questionnaires to measure their pain, opioid use, and recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPS-SelectTPS-Select is a computer-based tool that helps the research team identify patients who may be eligible for this study. It uses information that already exists in the medical record at the time a surgery is scheduled to estimate the chance of developing ongoing pain after surgery. This information can include details about the planned surgery, prior medical conditions, past surgeries, and previous use of pain medications. The tool runs automatically and is used only to help the research team decide whom to contact about possible participation in the study. The risk estimate created by this tool is not added to the medical record and is not seen by the patient's care team. Only approved members of the research team can see this information through a secure research system. | Device | Transitional Pain Service |
| Pharmacologic Pain ManagementAlso: Oxycodone Hydrochloride, Hydrocodone Bitartrate and Acetaminophen, Morphine Sulfate, Methadone HydrochlorideA pharmacist will meet with patients as part of the Transitional Pain Service before and after surgery. During this visit, the pharmacist will work with patients to create a personalized pain management plan, using the medications stated in this intervention to help safely and effectively control pain. This will guide patients on the proper use of opioid analgesics and non-opioid analgesics, including acetaminophen, non-steroid anti-inflammatory drugs, gabapentinoids, and topical medications to manage surgical pain. | Drug | Transitional Pain Service |
| Interventional Pain ProceduresAlso: Epidural Steroid Injection, Acupuncture, Trigger Point Injection, Peripheral Nerve BlockIf a patient has significant pain after their surgery, the care team may evaluate the patient for additional pain-relief options, such as the interventional pain procedures listed above. Local numbing medication or imaging studies may also be used to ensure the treatment is safe and appropriate. All anesthesiologists on the pain service are specially trained to perform these procedures. Only approved procedures will be offered, along with any imaging needed for evaluation. | Procedure or surgery | Transitional Pain Service |
| Psychological Management and Pain EducationPatients will be asked to complete short online pain education modules to help set expectations and prepare for pain after surgery. These materials are available at https://www.transitionalpainservice.ca/learn. Each patient will also be screened for mood-related concerns, including symptoms of depression, using a brief questionnaire. If a patient has significant symptoms of depression, they may be referred to a pain psychologist and, if needed, a UCSF psychiatrist for additional support. These visits may include proven approaches such as cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based strategies to help patients manage pain, cope with stress, and improve daily functioning. Patients with milder symptoms may be referred to group-based pain psychology sessions led by a pain psychologist. | Behavioural | Transitional Pain Service |
| Physical TherapyPatients will be assessed for their physical function and ability to carry out daily activities. If a patient has difficulty with mobility, strength, or endurance, they may be referred to physical or occupational therapy before surgery to help improve overall conditioning. Pre-surgery therapy may include exercises to strengthen the core, arms, and legs, improve balance, and build stamina, as well as an overall fitness assessment. Referrals will only be made if it is safe for the patient to participate, and standard safety checks-such as heart health and fall risk-will be completed beforehand. All therapy will be provided by a licensed physical therapist using established, evidence-based treatment plans. | Behavioural | Transitional Pain Service |
Primary outcome
Presence of Chronic Post-Surgical Pain
Time frame: 90 days after date of surgery
This outcome measures how many patients in each group (Standard of Care vs. Transitional Pain Service) have chronic post-surgical pain 90 days after date of surgery. Chronic post-surgical pain refers to worsening pain in a preoperative pain region or the development of pain in a new region.
4 secondary outcomes
Opioid Use After Surgery
Time frame: 30, 90, and 180 days after discharge from hospital
Pain Levels After Surgery
Time frame: 30, 90, and 180 days after discharge from the hospital
Healthcare Costs
Time frame: 30, 90, and 180 days after discharge from the hospital
Pain in Surgical Region
Time frame: 30 Days, 90 Days, 180 Days
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 9 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with outside researchers because the information collected in this study includes sensitive health details that could pose privacy risks if shared. Although all data are protected and stored securely, sharing IPD outside the study team may increase the chance of re-identification. To protect patient privacy, only summarized results that do not identify any individual will be shared publicly.
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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.
Andrew Bishara, MD principal investigator
UCSF Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TPS-Select, Pharmacologic Pain Management and Interventional Pain Procedures in people with Postsurgical Pain Management and Postsurgical Pain, Chronic, run by University of California, San Francisco 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?
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: opening soon, as of the sponsor's last update on 9 Oct 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Akash Shanmugam, BS (408-242-3095, akash.shanmugam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Chronic Post-Surgical Pain (time frame: 90 days after date of surgery). 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 9 Oct 2026.