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Search / Trial NCT05380531

Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Launched by SENTHIL SADHASIVAM · May 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Opioid Exposure

ClinConnect Summary

This clinical trial is investigating a new approach to managing pain for women who are having a cesarean section (C-section). The goal is to create a personalized pain relief system that can help reduce the use of opioids, which are strong pain medications, and minimize potential problems for both mothers and their babies, especially for breastfeeding mothers. By using this new method, researchers hope to improve recovery experiences and reduce any serious side effects related to opioid use.

To be eligible for this trial, participants must be adult women over 18 years old who are scheduled for an elective C-section and are open to receiving opioid pain relief while in the hospital. However, women with certain health conditions, a history of opioid misuse, or severe pain before the surgery cannot participate. If you join the trial, you can expect to receive personalized pain management support during and after your surgery. This study is currently looking for participants, and your involvement could help lead to better pain management strategies for future mothers.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Adult women (\>18 yr) All races American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section that are willing to receive in-patient opioids.
  • Exclusion Criteria:
  • 1. Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
  • 2. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
  • 3. Preoperative severe pain and opioid use/misuse, allergy to oxycodone
  • 4. Allergy to oxycodone
  • 5. Significant neurological disorders, liver and renal diseases

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

Pittsburgh, Pennsylvania, 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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