60 Participants Needed

Epidural Pain Management for Postoperative Pain

(PIBDOSE Trial)

NG
VB
Overseen ByVeronique Brulotte, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ciusss de L'Est de l'Île de Montréal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Programmed Intermittent Epidural Bolus (PIEB) for postoperative pain management?

Research shows that Programmed Intermittent Epidural Bolus (PIEB) provides better pain relief and requires fewer additional doses from doctors compared to continuous epidural infusion, especially in labor and post-cesarean delivery pain management.12345

Is programmed intermittent epidural bolus (PIEB) safe for humans?

Research on programmed intermittent epidural bolus (PIEB) for labor and post-cesarean pain management suggests it is generally safe, with benefits like reduced need for additional pain relief and less muscle weakness compared to continuous methods.12346

How is the treatment Programmed Intermittent Epidural Bolus (PIEB) different from other treatments for postoperative pain?

Programmed Intermittent Epidural Bolus (PIEB) is unique because it delivers pain relief in scheduled doses rather than a continuous flow, which can provide better pain control and reduce the need for additional medication compared to continuous epidural infusion (CEI). This method may also result in less muscle weakness, making it a potentially more comfortable option for patients.12456

What is the purpose of this trial?

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.

Research Team

vB

Veronique Brulotte, MD, MSc

Principal Investigator

Maisonneuve-Rosemont Hospital

Eligibility Criteria

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.
See 4 more

Timeline

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)

Treatment Details

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.
Participant Groups
12Treatment groups
Experimental Treatment
Group I: M9 mL PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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 PIEBExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials
81
Recruited
6,400+

Findings from Research

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.
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 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.
Programmed intermittent epidural bolus for post-cesarean delivery analgesia: a randomized controlled double-blind trial.Wang, L., Wu, Z., Hu, L., et al.[2023]
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.
Programmed intermittent epidural bolus in parturients: A meta-analysis of randomized controlled trials.Wang, XX., Zhang, XL., Zhang, ZX., et al.[2023]

References

Continuous epidural infusion versus programmed intermittent epidural bolus for labor analgesia: optimal configuration of parameters to reduce physician-administered top-ups. [2019]
Programmed intermittent epidural bolus for post-cesarean delivery analgesia: a randomized controlled double-blind trial. [2023]
Programmed intermittent epidural bolus in parturients: A meta-analysis of randomized controlled trials. [2023]
Programmed Intermittent Epidural Bolus in Comparison with Continuous Epidural Infusion for Uterine Contraction Pain Relief After Cesarean Section: A Randomized, Double-Blind Clinical Trial. [2022]
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. [2022]
Programmed intermittent epidural bolus as compared to continuous epidural infusion for the maintenance of labor analgesia: a prospective randomized single-blinded controlled trial. [2020]
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