Personalized Pain Management for Spinal Fusion
(PPAP Spine Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen bySenthilkumar Sadhasivam, MD, MPH
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Senthilkumar Sadhasivam
Must be taking: Opioids
Disqualifiers: Serious illness, Preoperative severe pain, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who are using opioids before surgery.
What data supports the effectiveness of the Personalized Perioperative Analgesia Platform (PPAP) treatment for pain management in spinal fusion surgery?
Research suggests that patient-controlled analgesia (PCA), a component of PPAP, is effective in managing postoperative pain by allowing patients to control their pain relief, which can lead to higher satisfaction and better pain management. Additionally, individualizing pain management strategies, as done in PPAP, is shown to improve outcomes by addressing each patient's unique pain perception and needs.
12345Is personalized pain management for spinal fusion safe for humans?
Patient-controlled analgesia (PCA), a method used in personalized pain management, is generally safe for humans, though it can have side effects like nausea, vomiting, and respiratory issues. These side effects are often related to opioid use and can be managed by adjusting doses and monitoring patients closely.
26789How is the Personalized Perioperative Analgesia Platform (PPAP) treatment different from other treatments for pain management after spinal fusion?
The Personalized Perioperative Analgesia Platform (PPAP) is unique because it likely offers a tailored approach to pain management, potentially combining different methods like patient-controlled analgesia (PCA) with personalized adjustments to better suit individual patient needs, unlike standard treatments that may not be as customizable.
2891011Eligibility Criteria
This trial is for children aged 10 to nearly 18, in good to moderate health (ASA status 1-3), who will need opioids during and after a specific back surgery called Posterior-Lateral Spinal Fusion. They can't join if they have serious illnesses, already suffer from severe pain before the operation, or use/misuse opioids beforehand.Inclusion Criteria
I was prescribed opioids when I was discharged.
I am between 10 and 17 years old.
I am currently receiving opioids in a hospital.
+2 more
Exclusion Criteria
I experience severe pain before surgery.
You have a severe medical condition.
You have been using or misusing opioids before your surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-operative
Preoperative CYP2D6 genotyping and collection of pharmacogenetic data
1 week
1 visit (in-person)
Surgery and Immediate Post-operative
Children undergo spine fusion surgery and immediate post-operative monitoring for opioid-adverse effects
4 days
Inpatient stay
Post-operative
Monitoring of genetic factors and personalized analgesia plan implementation
Up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of chronic persistent surgical pain and opioid dependence
Up to 1 year
Participant Groups
The study is developing a personalized pain management system for kids having spine fusion surgery. It involves preoperative genotyping—testing their genes—to tailor pain treatment and minimize opioid-related risks.
1Treatment groups
Experimental Treatment
Group I: Children undergoing Spine Fusion SurgeryExperimental Treatment1 Intervention
This arm will include approximately 300 children undergoing spine fusion surgery
1. Pharmacokinetic (PK): collection of 10-13 serial blood samples to determine serum levels of methadone/oxycodone and its metabolites
2. Pharmacogenetic (PG): Preoperative CYP2D6 genotyping (for preferential recruitment of CYP2D6 PMs and UMs). This will be collected in the pre-operative clinic via blood if there are clinical labs needed for standard of care. If no blood is needed in the pre-op clinic, the investigators will collect this via saliva.
Postoperative Analgesia Dose and PK Sampling Schedule:
Clinical care providers are blinded to CYP2D6/CYP2B6 when prescribing oxycodone/methadone; and genetic analysis of proposed targeted genes. Results of these samples will be used to determine personalized analgesia plan.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CaliforniaSan Francisco, CA
University of PittsburghPittsburgh, PA
UPMC Children's HospitalPittsburgh, PA
Riley Children's HospitalIndianapolis, IN
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Who Is Running the Clinical Trial?
Senthilkumar SadhasivamLead Sponsor
Senthil SadhasivamLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Early postoperative patient-controlled analgesia ratio predicts 24-hour morphine consumption and pain in children undergoing scoliosis surgery. [2014]The identification of patients at risk for developing severe postoperative pain and/or opioid-related side effects is difficult due to a lack of sensitive indicators. The patient-controlled analgesia (PCA) ratio of demands to deliveries is a potential tool for early identification of patients who experience severe postoperative pain. The authors hypothesized that the PCA ratio is able to predict morphine requirement in the first 24 hours after scoliosis surgery.
Children's use of PCA following spinal fusion. [2019]The purpose of this study was to examine the effectiveness of patient-controlled analgesia (PCA) in relieving postoperative pain for children and adolescents following spinal fusion.
The Predictive Value of Cold Pack Test for Pain After Third Molar Surgery. [2023]Early identification of patients who are prone to postoperative pain may provide individualization of postoperative analgesia strategies.
[Acute pain therapy in orthopedics/trauma surgery]. [2019]The management of acute pain is of utmost importance in the treatment regimen of orthopedic and trauma patients. Pain perception is different for each patient and has to be individually addressed. Especially in a postoperative setting often with a very dynamic course of pain, it is optimal that the pain management is adapted to the individual course of pain. In this situation it makes sense to apply patient-controlled systems. By combining different analgesic substance classes and non-pharmaceutical therapy in the sense of a multimodal concept, the mechanisms of action complement each other and side effects can be reduced. Patient satisfaction is higher when they are actively involved in the (medicinal) pain therapy and in the decision making. This is particularly important for patient-controlled analgesia (PCA). In addition to invasive catheter administration procedures, there are also modern approaches for oral individual self-administered opioid treatment.
[Continuous epidural perfusion with meperidine on demand for the treatment of postoperative pain]. [2013]To determine whether epidural administration of meperidine through a system affording patient-controlled analgesia (PCA) is appropriate for postoperative pain.
Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study. [2018]Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute.
[Patient-controlled analgesia]. [2011]Patient controlled analgesia (PCA) is a drug delivery system aimed to control acute pain using negative feedback technology in a closed loop system in which the patient plays an active role. It overcomes the inadequacies of traditional analgesic protocols due to marked differences in pharmacokinetic and dynamy of analgesis between patients. Moreover, doctors and nurses frequently underprescribe opioids in patients with severe pain for fear of dangerous side-effects. A safe and effective delivery of these drugs on patient demand can be achieved using various delivery systems, modes and dosing parameters. Most devices provide both demand dosing, where a constant predetermined dose is self administered, and constant rate infusion plus demand dosing, where the minimum administration rate is determined by the doctor, but can be supplemented by patient demand. Morphine sulphate remains the drug most commonly used in PCA therapy, but meperidine hydrochloride, alfentanil, nalbuphine and buprenorphine are also sometimes administered. The doctor determines the incremental dose per demand, the lockout interval, and the maximum dose per time unit, possibly also the loading dose and the minimum dose rate when a continuous flow is used. PCA provides improved analgesia, which is immediate and independent of nurse availability. This technique decreases opioid requirements, and the required total amounts are lowered. PCA gives patients both behavioural and decisional control. They can titrate the analgesic dose in such a way as to balance pain relief with the degree of side-effects, the patient is willing to tolerate. Patients often choose less than the available total dose of analgesic. The risks consists in the usual opioid side-effects, mainly respiratory depression. These may be due to mechanical problems, machine failure, or user incidents (misprogramming, or miscalculation of doses). Standards help to ensure consistent care and avoid errors that can occur even with handwritten orders. The principles of demand analgesia are now being investigated using other agents, such as local anaesthetics, and other routes of administration, mainly epidural injection. In most patients, even in children, PCA can replace intramuscular injections, which are the standard route for opioid administration. Today PCA and spinal opioids are the two main methods of analgesia for postoperative pain management.
Clinical Update on Patient-Controlled Analgesia for Acute Postoperative Pain. [2022]Patient-controlled analgesia (PCA) is an effective method for controlling acute pain, including postoperative pain in adults and in children from five years of age, pain resulting from labor, trauma, or other medical situations, or chronic and malignant pain. The treatment consists of a mini-computer-controlled infusion pump permitting the administration of on-demand, continuous, or combined doses of analgesic (mainly opioid) variations in response to therapy, which allows pain to be significantly controlled. Intravenous (IV)-PCA minimizes individual pharmacodynamics and pharmacokinetic differences and is widely accepted as a reference method for mild or severe postoperative pain. IV-PCA is the most studied route of PCA; other delivery methods have been extensively reported in the literature. In addition, IV-PCA usually voids the gap between pain sensation and analgesic administration, permitting better recovery and fewer side effects. The most commonly observed complications are nausea and vomiting, pruritus, respiratory depression, sedation, confusion and urinary retention. However, human factors such as pharmacy preparation and device programming can also be involved in the occurrence of these complications, while device failure is much less of an issue.
Patient-controlled versus conventional analgesia for postsurgical pain relief in adolescents. [2019]We performed a randomized nonblinded, cross-over comparison of patient-controlled analgesia (PCA) with conventional intramuscular analgesia in 10 adolescents (13-18 years) undergoing spinal fusion for idiopathic scoliosis. PCA use afforded more effective pain control (p
Comparison of patient-controlled epidural analgesia and patient-controlled intravenous analgesia after spinal fusion surgery: a meta-analysis of randomized controlled trials. [2018]The objective of this meta-analysis was to compare the efficacy and safety of patient-controlled epidural analgesia (PCEA) and patient-controlled intravenous analgesia (PCIA) in postoperative analgesia of spinal fusion surgery.
Postoperative analgesia after major spine surgery: patient-controlled epidural analgesia versus patient-controlled intravenous analgesia. [2006]Spinal fusion surgery causes severe postoperative pain, hampering reconvalescense. We investigated the efficacy of patient-controlled epidural analgesia (PCEA) in a prospective, double-blind, randomized, controlled comparison with patient-controlled IV analgesia (PCIA).