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Analgesic
Epidural Pain Management for Postoperative Pain (PIBDOSE Trial)
N/A
Recruiting
Led By veronique Brulotte, MD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-85 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 8 am until 8 pm on the first postoperative day
Awards & highlights
PIBDOSE Trial Summary
This trial aims to determine an optimal dose of epidural medication to control pain in patients having surgery with a large midline laparotomy incision. It also seeks to determine if men and women have different dosage needs.
Who is the study for?
This trial is for adults aged 18-85 with an ASA classification of I to III, who are undergoing open abdominal surgery and can have an epidural catheter placed. It's not suitable for those needing intensive care post-op, with coagulopathy, sepsis, local infection at the insertion site, daily opioid use or communication barriers.Check my eligibility
What is being tested?
The study aims to find the best dose of a pain control method called PIEB (Programmed intermittent epidural bolus) after abdominal surgery. Doses between 5 and 10 ml will be tested every hour on men and women separately to see which provides effective pain relief without too much need for additional doses.See study design
What are the potential side effects?
Possible side effects include motor block (weakness in muscles), low blood pressure (hypotension), varying levels of numbness depending on the dose (sensory block level), and differences in patient satisfaction and recovery quality scores.
PIBDOSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
PIBDOSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 8 am until 8 pm on the first postoperative day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 8 am until 8 pm on the first postoperative day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful analgesia
Secondary outcome measures
Incidence of hypotension according to group
Incidence of motor block according to group
Pain
+3 morePIBDOSE Trial Design
12Treatment groups
Experimental Treatment
Group I: M9 mL PIEBExperimental Treatment1 Intervention
Male patients in this group will receive a 9 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group II: M8 mL PIEBExperimental Treatment1 Intervention
Male patients in this group will receive a 8 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group III: M7 mL PIEBExperimental Treatment1 Intervention
Male patients in this group will receive a 7 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group IV: M6 mL PIEBExperimental Treatment1 Intervention
Male patients in this group will receive a 6 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group V: M5 ml PIEBExperimental Treatment1 Intervention
Male patients in this group will receive a 5 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group VI: M10 mL PIEBExperimental Treatment1 Intervention
Male patients in this group will receive a 10 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group VII: F9 ml PIEBExperimental Treatment1 Intervention
Female patients in this group will receive a 9 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group VIII: F8 ml PIEBExperimental Treatment1 Intervention
Female patients in this group will receive a 8 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group IX: F7 ml PIEBExperimental Treatment1 Intervention
Female patients in this group will receive a 7 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group X: F6 ml PIEBExperimental Treatment1 Intervention
Female patients in this group will receive a 6 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group XI: F5 ml PIEBExperimental Treatment1 Intervention
Female patients in this group will receive a 5 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Group XII: F10 ml PIEBExperimental Treatment1 Intervention
Female patients in this group will receive a 10 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.
Find a Location
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,500 Total Patients Enrolled
3 Trials studying Postoperative Pain
122 Patients Enrolled for Postoperative Pain
veronique Brulotte, MDPrincipal InvestigatorMaisonneuve-Rosemont Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have a catheter placed in your back for medication.You take opioid medication every day.I will be admitted to the ICU after my surgery.I have chosen not to participate in the trial.You have a mild to severe overall health condition.You are unable to use patient-controlled epidural analgesia (PCEA) or have difficulty communicating.I do not have bleeding disorders, severe infections, or objections to epidural anesthesia.I was excluded because I couldn't feel ice or needed surgery again within a day after my first operation.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: F5 ml PIEB
- Group 2: F6 ml PIEB
- Group 3: F7 ml PIEB
- Group 4: F8 ml PIEB
- Group 5: F9 ml PIEB
- Group 6: F10 ml PIEB
- Group 7: M5 ml PIEB
- Group 8: M6 mL PIEB
- Group 9: M7 mL PIEB
- Group 10: M8 mL PIEB
- Group 11: M9 mL PIEB
- Group 12: M10 mL PIEB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for participants in this research?
"According to the data on clinicaltrials.gov, this trial is currently seeking participants after first being posted in December 1st 2022 and most recently updated January 5th 2023."
Answered by AI
Does this clinical investigation accommodate individuals aged sixty and above?
"This research is only recruiting patients aged 18-85, however there are additional trials available for people younger than 18 and seniors over 65. Specifically, 66 experiments target participants under the age of majority and 348 studies focus on senior citizens."
Answered by AI
Am I eligible to volunteer for this clinical research?
"To be considered for participation in this research, candidates must have undergone laparotomy and abide by the age requirements of 18 to 85 years old. The current recruitment is aiming to enrol approximately 60 participants."
Answered by AI
How many participants have been enlisted in this research project?
"Correct. The research posted on clinicaltrials.gov shows that this ongoing medical trial, which began accepting applicants on December 1st 2022, is currently searching for 60 individuals from one location."
Answered by AI
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