Epidural Pain Management for Postoperative Pain

(PIBDOSE Trial)

Recruiting at 1 trial location

Overseen By Veronique Brulotte, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Must not be taking: Opioids

Disqualifiers: Coagulopathy, Sepsis, Communication barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 36 hours

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of a new pain relief method called Programmed Intermittent Epidural Bolus (PIEB) for individuals undergoing major abdominal surgery. The focus is on patients with large surgical incisions, as managing their pain can be challenging. Researchers will test different doses to assess if this method provides effective pain relief for both men and women. Ideal candidates for this trial are those planning to undergo open abdominal surgery with a large incision. As an unphased trial, this study offers participants the chance to contribute to innovative pain management solutions for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use opioids daily, you cannot participate in the trial.

What prior data suggests that this method is safe for postoperative pain management?

Research shows that the programmed intermittent epidural bolus (PIEB) method is generally safe for managing post-surgical pain. Studies have found PIEB to be as effective and safe as other pain relief methods after major abdominal surgery. In these studies, patients experienced good pain control with fewer side effects, such as temporary muscle weakness.

One study showed that PIEB reduced the need for extra doctor visits by 6.9% compared to another method, suggesting it is well-tolerated. Another study found that PIEB provided effective pain relief with less muscle weakness after a cesarean section.

The medications used in PIEB, such as bupivacaine, fentanyl, and epinephrine, are commonly used in epidurals and are known to be safe when used correctly. While every treatment carries risks, existing research supports PIEB as a generally safe option for pain control after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the programmed intermittent epidural bolus (PIEB) technique for postoperative pain management due to its potential to improve pain relief and patient comfort. Unlike traditional continuous epidural infusions, PIEB delivers controlled doses of anesthetics like bupivacaine, combined with fentanyl and epinephrine, at intervals, which can enhance the spread of medication and reduce motor block. This method might offer more consistent pain control while using less medication overall, potentially minimizing side effects and improving recovery experiences for patients after surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain management?

Studies have shown that Programmed Intermittent Epidural Bolus (PIEB) effectively manages post-surgical pain. PIEB offers better pain relief than continuous epidural infusion (CEI) and often reduces the need for additional pain medication. Research indicates that patients using PIEB report high satisfaction with their pain control. This trial will test different PIEB dosages to find the optimal dosage, with separate groups for male and female patients to explore any differences in effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Veronique Brulotte, MD, MSc

Principal Investigator

Maisonneuve-Rosemont Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with an ASA classification of I to III, who are undergoing open abdominal surgery and can have an epidural catheter placed. It's not suitable for those needing intensive care post-op, with coagulopathy, sepsis, local infection at the insertion site, daily opioid use or communication barriers.

Inclusion Criteria

You have a mild to severe overall health condition.

Exclusion Criteria

You cannot have a catheter placed in your back for medication.

You take opioid medication every day.

I will be admitted to the ICU after my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

1 visit (in-person)

Treatment

Participants receive programmed intermittent epidural bolus (PIEB) for postoperative analgesia after laparotomy

36 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Programmed intermittent epidural bolus

Trial Overview

The study aims to find the best dose of a pain control method called PIEB (Programmed intermittent epidural bolus) after abdominal surgery. Doses between 5 and 10 ml will be tested every hour on men and women separately to see which provides effective pain relief without too much need for additional doses.

How Is the Trial Designed?

Group I: M9 mL PIEB Experimental Treatment 1 Intervention

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

Group II: M8 mL PIEB Experimental Treatment 1 Intervention

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

Group III: M7 mL PIEB Experimental Treatment 1 Intervention

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

Group IV: M6 mL PIEB Experimental Treatment 1 Intervention

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

Group V: M5 ml PIEB Experimental Treatment 1 Intervention

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

Group VI: M10 mL PIEB Experimental Treatment 1 Intervention

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

Group VII: F9 ml PIEB Experimental Treatment 1 Intervention

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

Group VIII: F8 ml PIEB Experimental Treatment 1 Intervention

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

Group IX: F7 ml PIEB Experimental Treatment 1 Intervention

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

Group X: F6 ml PIEB Experimental Treatment 1 Intervention

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

Group XI: F5 ml PIEB Experimental Treatment 1 Intervention

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

Group XII: F10 ml PIEB Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Published Research Related to This Trial

In a study of 58 women after cesarean delivery, programmed intermittent epidural boluses (PIEB) provided better pain relief at 12 hours compared to continuous epidural infusion (CEI), with lower pain scores at rest and during movement.

PIEB also resulted in reduced total ropivacaine consumption over 48 hours compared to CEI, indicating it may be a more efficient method for postoperative pain management without compromising analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus for post-cesarean delivery analgesia: a randomized controlled double-blind trial. Wang, L., Wu, Z., Hu, L., et al.[2023]

In a study of 90 term nulliparous women in labor, a slower delivery speed of 125 mL·hr-1 for programmed intermittent epidural bolus (PIEB) did not result in lower sensory block levels compared to a faster speed of 250 mL·hr-1.

However, the slower delivery speed was associated with a significantly lower incidence of hypotension (11.1% vs 33.3%), suggesting a potential safety benefit that needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus for labour analgesia: a randomized controlled trial comparing bolus delivery speeds of 125 mL·hr-1 versus 250 mL·hr-1. Mazda, Y., Arzola, C., Downey, K., et al.[2022]

In a study of 150 patients, the programmed intermittent epidural bolus (PIEB) technique with 10 ml every 60 minutes (Group 10q60) resulted in significantly fewer patients needing physician-administered boluses for breakthrough pain compared to other regimens, indicating improved management of pain during labor.

Although overall pain scores and patient satisfaction were similar across all groups, the PIEB technique may offer a more effective approach to maintaining labor analgesia with less reliance on additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus as compared to continuous epidural infusion for the maintenance of labor analgesia: a prospective randomized single-blinded controlled trial. Fidkowski, CW., Shah, S., Alsaden, MR.[2020]

In a study involving 405 women in labor, the programmed intermittent epidural bolus (PIEB) delivery method at 45-minute intervals significantly reduced the number of women requesting physician-administered top-ups (PATUs) compared to continuous epidural infusion (CEI) and PIEB at 60-minute intervals.

The PIEB45HF setting, which used a high flow rate, also resulted in fewer PATUs, indicating that adjusting the timing and flow of epidural boluses can enhance labor analgesia effectiveness without compromising other obstetric outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous epidural infusion versus programmed intermittent epidural bolus for labor analgesia: optimal configuration of parameters to reduce physician-administered top-ups. Delgado, C., Ciliberto, C., Bollag, L., et al.[2019]

In a study of 120 parturients undergoing cesarean sections, programmed intermittent epidural bolus (PIEB) provided significantly better relief from uterine contraction pain compared to continuous epidural infusion (CEI), as measured by visual analog scale scores at 36 hours post-surgery.

PIEB also resulted in less motor block than CEI, with no increase in adverse events like hypotension or urinary retention, indicating it is a safer and more effective option for pain management after cesarean delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Intermittent Epidural Bolus in Comparison with Continuous Epidural Infusion for Uterine Contraction Pain Relief After Cesarean Section: A Randomized, Double-Blind Clinical Trial. Mo, X., Zhao, T., Chen, J., et al.[2022]

Programmed intermittent epidural bolus (PIEB) significantly reduces the total consumption of pain medications like ropivacaine and sufentanil, leading to better pain management during labor.

PIEB is associated with higher rates of normal deliveries, shorter labor durations, and improved patient satisfaction scores, along with better neonatal outcomes as indicated by higher Apgar scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus in parturients: A meta-analysis of randomized controlled trials. Wang, XX., Zhang, XL., Zhang, ZX., et al.[2023]

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