Recruiting

PIB

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT05534945

Conditions

Acute Post Operative Pain

Laparotomy

Epidural Analgesia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Programmed intermittent epidural bolus 5 ml

Programmed intermittent epidural bolus 6 ml

Programmed intermittent epidural bolus 7 ml

Programmed intermittent epidural bolus 8 ml

Programmed intermittent epidural bolus 9 ml

Study Details

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.

Conditions

Acute Post Operative Pain

Laparotomy

Epidural Analgesia

Study ID

NCT05534945

Start date

Dec 1, 2022

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: F5 ml PIEB

Female patients in this group will receive a 5 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: F6 ml PIEB

Female patients in this group will receive a 6 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: F7 ml PIEB

Female patients in this group will receive a 7 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: F8 ml PIEB

Female patients in this group will receive a 8 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: F9 ml PIEB

Female patients in this group will receive a 9 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: F10 ml PIEB

Female patients in this group will receive a 10 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: M5 ml PIEB

Male patients in this group will receive a 5 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: M6 mL PIEB

Male patients in this group will receive a 6 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: M7 mL PIEB

Male patients in this group will receive a 7 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: M8 mL PIEB

Male patients in this group will receive a 8 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: M9 mL PIEB

Male patients in this group will receive a 9 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

experimental: M10 mL PIEB

Male patients in this group will receive a 10 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg/ml + epinephrine 2mcg/ml.

Interventions

Programmed intermittent epidural bolus 5 ml

patients in this group will receive a programmed epidural intermittent bolus of 5 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain > 4/10

Programmed intermittent epidural bolus 6 ml

patients in this group will receive a programmed epidural intermittent bolus of 6 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain > 4/10

Programmed intermittent epidural bolus 7 ml

patients in this group will receive a programmed epidural intermittent bolus of 7 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain > 4/10

Programmed intermittent epidural bolus 8 ml

patients in this group will receive a programmed epidural intermittent bolus of 8 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain > 4/10

Programmed intermittent epidural bolus 9 ml

patients in this group will receive a programmed epidural intermittent bolus of 9 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain > 4/10

Programmed intermittent epidural bolus 10 ml

patients in this group will receive a programmed epidural intermittent bolus of 10 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain > 4/10

Primary outcome measure

  • Successful analgesia [ Time Frame: from 8 AM until 8 PM on the first postoperative day ]

Central Contacts and Locations

Central contacts

Veronique Brulotte, MD

514252-3400veronique.brulotte@umontreal.ca

Nadia Godin, RN

514 252-3400ngodin.hmr@ssss.gouv.qc.ca

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T2m4

Contacts

Veronique Brulotte, MD

veronique.brulotte@umontreal.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2025-11-14.