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

Recruiting now · Not applicable

Conditions studied: Acute Post Operative Pain, Laparotomy, Epidural Analgesia

In brief

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.

Key facts

Study ID

NCT05534945

Run by

Ciusss de L'Est de l'Île de Montréal

People needed

60

Starts

2022-12-01

Expected to finish

2026-12-01

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-85 years old
• ASA I to III

You may not qualify if…

• 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

Where it is running

• Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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