An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service

NCT07296770 | Not Yet Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: 24-42631
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postsurgical Pain Management; Postsurgical Pain, Chronic; Opioid Use After Surgery

Keywords

Pain; Transitional Pain Service; Postsurgical Pain; Postoperative Opioid Use

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With 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 pain that starts after surgery and lasts longer than 3 months, gets worse after 3 months, or spreads to nearby nerves or areas connected to the surgical site. To make this diagnosis, other causes-such as infection, cancer, or pain conditions from before surgery-must be ruled out.

  90 days after date of surgery

Secondary Outcomes (3)

• Opioid Use After Surgery

  30, 60, and 90 days after discharge from hospital

• Pain Levels After Surgery

  30, 60, and 90 days after discharge from the hospital

• Healthcare Costs

  30, 60, and 90 days after discharge from the hospital

Study Arms (2)

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.

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 and will also have the option of a pharmacist wellness check-in at 60 days after surgery.

Interventions

Interventional Pain Procedures PROCEDURE

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.

Also known as: Epidural Steroid Injection, Acupuncture, Trigger Point Injection, Peripheral Nerve Block, Joint Injection, Radiofrequency Ablation

Transitional Pain Service

Psychological Management and Pain Education BEHAVIORAL

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.

Transitional Pain Service

Physical Therapy BEHAVIORAL

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.

Transitional Pain Service

TPS-Select DEVICE

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.

Transitional Pain Service

Pharmacologic Pain Management DRUG

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.

Also known as: Oxycodone Hydrochloride, Hydrocodone Bitartrate and Acetaminophen, Morphine Sulfate, Methadone Hydrochloride, Buprenorphine, Gabapentin, Duloxetine Hydrochloride, Pregabalin, Amitriptyline Hydrochloride, Nortriptyline Hydrochloride

Transitional Pain Service

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 1 month 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Hospitals

San Francisco, California, 94131, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Oxycodone; Hydrocodone; Acetaminophen; Morphine; Methadone; Buprenorphine; Gabapentin; Duloxetine Hydrochloride; Pregabalin; Amitriptyline; Nortriptyline; Acupuncture Therapy; Injections, Intra-Articular; Radiofrequency Ablation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ketones; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Dibenzocycloheptenes; Benzocycloheptenes; Hydrocarbons, Aromatic; Complementary Therapies; Therapeutics; Injections; Drug Administration Routes; Drug Therapy; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative; Rehabilitation

Study Officials

• Andrew Bishara, MD

  UCSF Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akash Shanmugam, BS

CONTACT

408-242-3095; akash.shanmugam@ucsf.edu

Madeline Holt, BS

CONTACT

978-317-9071; madeline.holt@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 makes sure patients are evenly matched based on their level of risk. All patients in the study are considered high-risk, but the investigators will sort them into three groups-mildly severe, moderately severe, and extremely severe-to help ensure that similar patients are compared fairly across both study arms.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: December 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)