Epidural Pain Management for Postoperative Pain
(PIBDOSE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you use opioids daily, you cannot participate in the trial.
What data supports the effectiveness of the treatment Programmed Intermittent Epidural Bolus (PIEB) for postoperative pain management?
Is programmed intermittent epidural bolus (PIEB) safe for humans?
How is the treatment Programmed Intermittent Epidural Bolus (PIEB) different from other treatments for postoperative pain?
Programmed Intermittent Epidural Bolus (PIEB) is unique because it delivers pain relief in scheduled doses rather than a continuous flow, which can provide better pain control and reduce the need for additional medication compared to continuous epidural infusion (CEI). This method may also result in less muscle weakness, making it a potentially more comfortable option for patients.12456
What is the purpose of this trial?
Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions.To address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication.Only a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision.However, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia.Hence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups.The primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day.Secondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group.
Research Team
Veronique Brulotte, MD, MSc
Principal Investigator
Maisonneuve-Rosemont Hospital
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive programmed intermittent epidural bolus (PIEB) for postoperative analgesia after laparotomy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Programmed intermittent epidural bolus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor