Programmed Intermittent Epidural Bolus for Postoperative Analgesia After Laparotomy: Determining the Optimum Dose Using a Biaised Coin Up-and-down Sequential Allocation Protocol

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 18-85 years old

• ASA I to III

Locations
Other Locations
Canada
Maisonneuve-Rosemont Hospital
RECRUITING
Montreal
Contact Information
Primary
Veronique Brulotte, MD
veronique.brulotte@umontreal.ca
514252-3400
Backup
Nadia Godin, RN
ngodin.hmr@ssss.gouv.qc.ca
514 252-3400
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ciusss de L'Est de l'Île de Montréal

This content was sourced from clinicaltrials.gov