Actively Recruiting
PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose
Led by Ciusss de L'Est de l'Île de Montréal · Updated on 2025-11-14
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- ASA physical status classification I to III
You will not qualify if you...
- Contraindications to thoracic epidural analgesia such as coagulopathy, sepsis, or local infection at the epidural site
- Inability to place the epidural catheter
- Inability to use the patient-controlled epidural analgesia pump or communication barriers
- Daily opioid use
- Planned postoperative admission to intensive care unit
- Patient refusal to participate
- Failure to obtain sensory block to ice in the post-anesthesia care unit
- Reoperation within one postoperative day
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T2m4
Actively Recruiting
Research Team
V
Veronique Brulotte, MD
CONTACT
N
Nadia Godin, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
12
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