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

Study acronym: PIBDOSE
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Notable Lead sponsor: Ciusss de L'Est de l'Île de Montréal to Ciusss de L'Est de l'Île de Montréal Show 7 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Jul 2026 to Sep 30, 2026
    • Study completion date changed from estimate of Dec 2026 to Oct 2, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 17 words
    • Site details revised
  2. Notable Primary completion date: Jul 2025 to Jul 2026
    • Study completion date: Dec 2025 to Dec 2026
    v8
  3. Notable Primary completion date: Dec 2024 to Jul 2025
    • Study completion date: Apr 2025 to Dec 2025
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Notable Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Apr 2024 to Apr 2025
    v5
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2022 to Dec 1, 2022
    v4
  2. Notable Enrollment target: 40 to 60v3 Show 5 more changesShow less
    • Start date: Oct 2022 to Dec 2022
    • Primary completion date: Oct 2023 to Dec 2023
    • Study completion date: Mar 2024 to Apr 2024
    • Study description expanded, about 106 words
    • Study arms: 6 to 12
  3. Minor Study description expanded, about 1 wordv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05534945
Lead Sponsor Ciusss de L'Est de l'Île de Montréal
Conditions
(from sponsor)
Acute Post Operative Pain, Laparotomy, Epidural Analgesia
Related terms Postoperative Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov