drugset / Trial / NCT03825198

Lumbar Erector Spinae Plane Block for Back Surgery

NCT03825198

Phase 3 Unknown 80 enrolled Dr M. B. Breebaart
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Title: A prospective randomized double blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24 h morphine consumption after posterior lumbar interbody fusion surgery. Objectives: The primary objective is to study the influence of a bilateral erector spinae block on 24h morphine consumption. Endpoint: The primary endpoint is the 24 h morphine consumption in mg. Secondary endpoints are intraoperative sufentanil requirement, total morphine during first 72 postoperative hours, NRS pain scores in rest and defined movement (moving to chair) at regular time intervals and Quality of Recovery 40 score (QoR-40) at fixed time intervals day 1 and 3 postoperatively Population: Patients undergoing posterior lumbar interbody fusion ranging 1 - 3 levels Phase 3 Number of sites Enrolling participants: University Hospital Antwerp \&AZ KLINA Brasschaat Description of study agent: Bilateral erector spinae block: each block contains 20 ml levobupivacaine 0.25% + 5 mcg/ml epinephrine Study duration Until the required study population is met Participant duration 72 hours

Timeline

Start
2019-08-01
Primary completion
2023-12-15
Completion
2023-12-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levobupivacaine Other / unclassified 0.25 % Other
Comparator Levobupivacaine Other / unclassified 20 ml Other
Comparator Acetaminophen Small molecule 1 g
Comparator Dexamethasone Small molecule 5 mg Intravenous
Comparator Ketorolac Other / unclassified 0.5 mg/kg Intravenous
Comparator Morphine Other / unclassified 1 mg Intravenous
Comparator Propofol Small molecule 2 mg/kg
Comparator Propofol Small molecule 3 mg/kg
Comparator Rocuronium Other / unclassified 0.5 mg/kg
Comparator Sevoflurane Other / unclassified Inhaled
Comparator Sufentanil Other / unclassified 15 ug
Comparator dehydrobenzperidol Unknown 0.05 mg/ml