UCSF Hospitals
San Francisco, California, 94131, United States
NCT Number: NCT07296770
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
San Francisco, California, 94131, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients may take part in this study if they:
Patients cannot take part if they:
A patient who has already joined may be removed from the study if they:
Patients may remain enrolled but their data may not be used in the main study results if they experience:
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.
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, Hydrocodone Bitartrate and Acetaminophen, Morphine Sulfate, Methadone Hydrochloride, Buprenorphine, Gabapentin, Duloxetine Hydrochloride, Pregabalin, Amitriptyline Hydrochloride, Nortriptyline Hydrochloride
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: Epidural Steroid Injection, Acupuncture, Trigger Point Injection, Peripheral Nerve Block, Joint Injection, Radiofrequency Ablation
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.
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.
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 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.
Time frame: 30, 60, and 90 days after discharge from hospital
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.
Time frame: 30, 60, and 90 days after discharge from the hospital
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.
Time frame: 30, 60, and 90 days after discharge from the hospital
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.
Contact information is provided by the study sponsor or research team.
Akash Shanmugam, BS
CONTACT
Madeline Holt, BS
CONTACT
University of California, San Francisco
Other
Acronym: TPS-Select
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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