F5 ml PIEB for Laparotomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Laparotomy+2 MoreProgrammed intermittent epidural bolus 7 ml - Drug
Eligibility
18 - 85
All Sexes
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Study 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.

Eligible Conditions
  • Acute Postoperative Pain
  • Laparotomy
  • Epidural Analgesia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: from 8 AM until 8 PM on the first postoperative day

At 24h postoperatively
Incidence of hypotension according to group
Incidence of motor block according to group
level of sensory block to ice according to group
At 48 h postoperatively
Quality of Recovery-15 (QoR-15) score
at 24h postoperatively
Pain
Pain score with movement-24h
from 8 AM until 8 PM on the first postoperative day
Successful analgesia

Trial Safety

Trial Design

18 Treatment Groups

F5 ml PIEB
1 of 18
7 ml PIEB
1 of 18
M5 ml PIEB
1 of 18
M10 mL PIEB
1 of 18
M6 mL PIEB
1 of 18
M9 mL PIEB
1 of 18
M7 mL PIEB
1 of 18
10 ml PIEB
1 of 18
9 ml PIEB
1 of 18
F9 ml PIEB
1 of 18
F6 ml PIEB
1 of 18
M8 mL PIEB
1 of 18
F10 ml PIEB
1 of 18
6 ml PIEB
1 of 18
5 ml PIEB
1 of 18
F7 ml PIEB
1 of 18
F8 ml PIEB
1 of 18
8 ml PIEB
1 of 18

Experimental Treatment

60 Total Participants · 18 Treatment Groups

Primary Treatment: F5 ml PIEB · No Placebo Group · N/A

F5 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 5 ml · Intervention Types: Drug
7 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 7 ml · Intervention Types: Drug
M5 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 5 ml · Intervention Types: Drug
M10 mL PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 10 ml · Intervention Types: Drug
M6 mL PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 6 ml · Intervention Types: Drug
M9 mL PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 9 ml · Intervention Types: Drug
M7 mL PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 7 ml · Intervention Types: Drug
10 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 10 ml · Intervention Types: Drug
9 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 9 ml · Intervention Types: Drug
F9 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 9 ml · Intervention Types: Drug
F6 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 6 ml · Intervention Types: Drug
M8 mL PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 8 ml · Intervention Types: Drug
F10 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 10 ml · Intervention Types: Drug
6 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 6 ml · Intervention Types: Drug
5 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 5 ml · Intervention Types: Drug
F7 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 7 ml · Intervention Types: Drug
F8 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 8 ml · Intervention Types: Drug
8 ml PIEB
Drug
Experimental Group · 1 Intervention: Programmed intermittent epidural bolus 8 ml · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 8 am until 8 pm on the first postoperative day

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
51 Previous Clinical Trials
3,375 Total Patients Enrolled
veronique Brulotte, MDPrincipal InvestigatorMaisonneuve-Rosemont Hospital

Eligibility Criteria

Age 18 - 85 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an ASA classification of I to III.