Epidural Pain Management for Postoperative Pain

(PIBDOSE Trial)

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

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 4 5 6}

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

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.

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

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+

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.

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 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]

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]

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]

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]

References

1. England 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. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus for post-cesarean delivery analgesia: a randomized controlled double-blind trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Programmed intermittent epidural bolus in parturients: A meta-analysis of randomized controlled trials. [2023]

4. New Zealand 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. [2022]

5. United States 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. [2022]

6. Korea (South) 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. [2020]