An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service (TPS-Select)

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 Overview

• Status: Not yet recruiting
• Conditions: Postsurgical Pain Management; Postsurgical Pain, Chronic; Opioid Use After Surgery
• Intervention / Treatment: Device: TPS-Select; Drug: Pharmacologic Pain Management; Procedure: Interventional Pain Procedures; Behavioral: Psychological Management and Pain Education; Behavioral: Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Akash Shanmugam, BS; Phone Number: 408-242-3095; Email: akash.shanmugam@ucsf.edu
• Study Contact Backup: Name: Madeline Holt, BS; Phone Number: 978-317-9071; Email: madeline.holt@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94131
      • UCSF Hospitals
      • Contact: Andrew Bishara, MD; Phone Number: 419-266-4764; Email: andrew.bishara@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transitional Pain Service; 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; 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.; Drug: Pharmacologic Pain Management; 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.; Other Names: Oxycodone Hydrochloride; Gabapentin; Buprenorphine; Methadone Hydrochloride; Pregabalin; Morphine Sulfate; Duloxetine Hydrochloride; Hydrocodone Bitartrate and Acetaminophen; Amitriptyline Hydrochloride; Nortriptyline Hydrochloride; Procedure: Interventional Pain Procedures; 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.; Other Names: Acupuncture; Peripheral Nerve Block; Radiofrequency Ablation; Trigger Point Injection; Epidural Steroid Injection; Joint Injection; Behavioral: Psychological Management and Pain Education; 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.; Behavioral: Physical Therapy; 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.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30, 60, and 90 days after discharge from hospital
Pain Levels After Surgery	This outcome looks at patients' reported pain scores over time. The study will compare average pain levels between the two groups to understand how the program affects recovery.	30, 60, and 90 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.	30, 60, and 90 days after discharge from the hospital

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Andrew Bishara, MD, UCSF Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Postsurgical Pain; Transitional Pain Service; Postoperative Opioid Use
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Therapeutics; Surgical Procedures, Operative; Drug Administration Routes; Drug Therapy; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Complementary Therapies; Acids, Acyclic; Carboxylic Acids; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Amino Acids; Rehabilitation; Heterocyclic Compounds, 4 or More Rings; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Thiophenes; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Dibenzocycloheptenes; Benzocycloheptenes; Morphine Derivatives; Ketones; Cyclohexanecarboxylic Acids; Codeine; Ablation Techniques; Radiofrequency Therapy; Injections; Duloxetine Hydrochloride; Gabapentin; Pregabalin; Acetaminophen; Morphine; Buprenorphine; Methadone; Oxycodone; Hydrocodone; Amitriptyline; Nortriptyline; Acupuncture Therapy; Physical Therapy Modalities; Radiofrequency Ablation; Injections, Intra-Articular
• Other Study ID Numbers: 24-42631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes