Determining the best dose of epidural pain relief after abdominal surgery
Programmed Intermittent Epidural Bolus for Postoperative Analgesia After Laparotomy: Determining the Optimum Dose Using a Biaised Coin Up-and-down Sequential Allocation Protocol
This study is testing the best amount of epidural pain relief for men and women after they have open abdominal surgery to see if it helps them feel better on the first day after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05534945 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the optimal volume dosage of epidural bupivacaine administered using a Programmed Intermittent Epidural Bolus (PIEB) protocol for patients undergoing elective open abdominal surgery with large incisions. The research will utilize a biased coin up-down sequential allocation method to determine the effective dose separately for men and women, addressing potential sex-based differences in pain management. Patients will be screened preoperatively, and informed consent will be obtained on the day of surgery. The study will focus on achieving effective analgesia in 90% of patients on the first postoperative day.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 undergoing elective open abdominal surgery with a midline incision greater than 25 cm.
Not a fit: Patients with contraindications to thoracic epidural analgesia or those requiring intensive care postoperatively may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing major abdominal surgeries.
How similar studies have performed: While some studies have explored the PIEB approach, results have been conflicting, making this investigation both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: veronique Brulotte, MD — Maisonneuve-Rosemont Hospital
- Study coordinator: Veronique Brulotte, MD
- Email: veronique.brulotte@umontreal.ca
- Phone: 514252-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.