NCT05534945 PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose
| NCT ID | NCT05534945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ciusss de L'Est de l'Île de Montréal |
| Condition | Acute Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-12-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
veronique Brulotte, MD
PRINCIPAL INVESTIGATOR
Maisonneuve-Rosemont Hospital
Frequently Asked Questions
Who can join the NCT05534945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Acute Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05534945 currently recruiting?
Yes, NCT05534945 is actively recruiting participants. Contact the research team at veronique.brulotte@umontreal.ca for enrollment information.
Where is the NCT05534945 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05534945 clinical trial?
NCT05534945 is sponsored by Ciusss de L'Est de l'Île de Montréal. The principal investigator is veronique Brulotte, MD at Maisonneuve-Rosemont Hospital. The trial plans to enroll 60 participants.