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Search / Trial NCT05367609

Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)

Launched by SENTHIL SADHASIVAM · May 4, 2022

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Ppap Pediatric Spine Fusion Surgery

ClinConnect Summary

This clinical trial is looking at a new way to manage pain for children who are having spine surgery, specifically a procedure called Posterior-Lateral Spinal Fusion. The goal is to create a personalized pain relief plan that helps reduce the use of opioids, which are strong pain medications that can have serious side effects. By improving how pain is managed before, during, and after surgery, the researchers hope to make the experience safer and more comfortable for young patients.

To participate, children aged 10 to 21 who are in good health (ASA physical status 1 to 3) and are scheduled for this specific spinal surgery can enroll. They should be receiving opioids during their hospital stay and will need to have a prescription for opioids when they go home. However, children with serious illnesses, severe pain before surgery, or a history of opioid misuse will not be eligible. Participants can expect to receive tailored pain management strategies, and their progress will be monitored closely throughout the study. This trial is currently recruiting participants, and it offers a chance to contribute to important research that could improve pain management for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children ages 10 to 21
  • ASA physical status 1 to 3
  • Undergoing Posterior-Lateral Spinal Fusion
  • Receives in-patient opioids
  • Prescribed opioids at discharge
  • Exclusion Criteria:
  • Serious illness
  • Preoperative severe pain
  • Preoperative opioid use or misuse

About Senthil Sadhasivam

Senthil Sadhasivam is a dedicated clinical trial sponsor with a focus on advancing medical research through innovative and rigorous study designs. Committed to improving patient outcomes, Sadhasivam leverages extensive expertise in clinical methodologies and regulatory compliance to facilitate the development of new therapies. By fostering collaborations with healthcare professionals and research institutions, he aims to contribute to the understanding of complex medical conditions and enhance treatment options available to patients. With a strong emphasis on ethical practices and patient safety, Senthil Sadhasivam is positioned as a reliable partner in the clinical research landscape.

Locations

Pittsburgh, Pennsylvania, United States

Indianapolis, Indiana, United States

Pittsburgh, Pennsylvania, United States

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Senthilkumar Sadhasivam, MD, MPH

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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