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Search / Trial NCT05534945

PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose

Launched by CIUSSS DE L'EST DE L'ÎLE DE MONTRÉAL · Sep 8, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on finding the best dose of a pain relief method called Programmed Intermittent Epidural Bolus (PIEB) for patients who have undergone open abdominal surgery, specifically those with a large incision. After surgery, managing pain effectively is essential for recovery, and while a common method called Thoracic Epidural Analgesia (TEA) is often used, some patients still experience pain. This study aims to determine the optimal PIEB dose for both men and women separately, to see how well it controls pain on the first day after surgery.

To participate in this trial, individuals must be between 18 and 85 years old and generally healthy (ASA I to III). However, those with certain medical conditions, such as bleeding disorders or infections, or those who refuse to participate, cannot join. Participants can expect to receive the PIEB at set intervals and be monitored for pain relief, any side effects, and overall satisfaction with their recovery. This research is important as it may improve pain management strategies for patients recovering from major surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 18-85 years old
  • ASA I to III
  • Exclusion Criteria:
  • Contraindication to TEA: Coagulopathy, sepsis or local infection at the epidural insertion site, patient refusal
  • Inability to site the epidural catheter
  • Inability to use PCEA/Communication barrier
  • Daily opioid use
  • Planned postoperative admission to the intensive care unit
  • Patient refusal
  • Predefined criteria for exclusion after inclusion: Failure to obtain a sensory block to ice in the Post Anesthesia Care Unit (PACU)(see Methods), Reoperation within 1 postoperative day

About Ciusss De L'est De L'île De Montréal

Ciusss de l'Est de l'Île de Montréal is a leading healthcare organization dedicated to enhancing the health and well-being of the communities it serves. As a prominent clinical trial sponsor, Ciusss de l'Est conducts innovative research aimed at advancing medical knowledge and improving patient outcomes. With a focus on collaboration and ethical standards, the organization fosters a multidisciplinary approach to clinical research, ensuring rigorous methodologies and comprehensive patient care. Through its commitment to scientific excellence and community health, Ciusss de l'Est plays a vital role in shaping the future of healthcare in the region.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

veronique Brulotte, MD

Principal Investigator

Maisonneuve-Rosemont Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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