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

NCT05534945 | Recruiting

• 1 other identifier: PIBdosefinding
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Successful analgesia

  Defined by a requirement of a maximum of 5 Patient controlled epidural analgesia (PCEA) boluses on postoperative day 1

  from 8 AM until 8 PM on the first postoperative day

Secondary Outcomes (6)

• Incidence of motor block according to group

  At 24h postoperatively

• Incidence of hypotension according to group

  At 24h postoperatively

• level of sensory block to ice according to group

  At 24h postoperatively

• Quality of Recovery-15 (QoR-15) score

  At 48 h postoperatively

• Pain score at rest-24h

  at 24h postoperatively

Study Arms (12)

F5 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 5 ml

F6 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 6 ml

F7 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 7 ml

F8 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 8 ml

F9 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 9 ml

F10 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 10 ml

M5 ml PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 5 ml

M6 mL PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 6 ml

M7 mL PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 7 ml

M8 mL PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 8 ml

M9 mL PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 9 ml

M10 mL PIEB

EXPERIMENTAL

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

Drug: Programmed intermittent epidural bolus 10 ml

Interventions

Programmed intermittent epidural bolus 5 ml DRUG

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

Also known as: 5 mL

F5 ml PIEB; M5 ml PIEB

Programmed intermittent epidural bolus 6 ml DRUG

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

Also known as: 6 mL

F6 ml PIEB; M6 mL PIEB

Programmed intermittent epidural bolus 7 ml DRUG

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

Also known as: 7 mL

F7 ml PIEB; M7 mL PIEB

Programmed intermittent epidural bolus 8 ml DRUG

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

Also known as: 8 mL

F8 ml PIEB; M8 mL PIEB

Programmed intermittent epidural bolus 9 ml DRUG

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

Also known as: 9 mL

F9 ml PIEB; M9 mL PIEB

Programmed intermittent epidural bolus 10 ml DRUG

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

Also known as: 10 mL

F10 ml PIEB; M10 mL PIEB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2m4, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• veronique Brulotte, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique Brulotte, MD

CONTACT

514252-3400; veronique.brulotte@umontreal.ca

Nadia Godin, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group allocation will be concealed in an opaque envelope that will be opened by a PACU nurse in order to program the epidural infusion pump according to the allocated group: f5, f6, f7, f8, f9, f10, or m5, m6, m7, m8, m9 or m10 mL. The pump will be started with the first bolus 30 min after the epidural loading dose at the end of the surgery. This nurse is otherwise not involved in the patient's care or in the research project. After programing the pump, the pump will be covered by an opaque plastic bag in order to maintain blinding. Out of concern for patient safety, health care providers involved in the management of patient care will have access to the information on pump settings through the research pharmacy, if needed. Subjects and outcome assessors will be blinded to the allocation group throughout the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The biaised coin up-and-down allocation method will be used and is described below for women. The same approach will be used for men. The PIEB dose for the first female patient will be set at 5 mL. Subsequent doses for the following female patients will be determined by the response of the previous female patient. The doses studied will be 5, 6, 7, 8, 9, and 10 mL. If a patient does not respond successfully to a dose, the dose for the next patient will be increased by 1 mL. If a patient responds successfully, the dose for the next patient will decrease by 1 mL with a probability of 1/9. Otherwise the dose will remain unchanged. In case of successful response in group 5 mL or a failure in group 10 mL, the dose for the subsequent patient would remain the same until the biased-coin program indicated to increase or decrease. The biaised-coin allocation after each successful response will be implemented using a computer-generated list of random responses.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)