Lumbar Erector Spinae Plane Block for Back Surgery

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr M. B. Breebaart
• Treatments: Acetaminophen; Anesthetics; BB 1101; Bromides; Bupivacaine; Dexamethasone; Dexamethasone acetate; Epinephrine; Epinephryl borate; Ketorolac; Ketorolac Tromethamine; Levobupivacaine; Morphine; Propofol; Racepinephrine; Rocuronium; Sevoflurane; Sufentanil

Criteria

Inclusion Criteria:

• - Patients scheduled for 1-2 level posterior lumbar interfusion surgery in AZ KLINA Hospital or University of Antwerp Hospital (UZA) after approval of Ethical Committee until all required patients are included

• American Society of Anesthesiologist (ASA) score of 1 - 3

• Age 18 - 75 year

• Normal liver and renal function

Exclusion Criteria:

• Age <18 years or mentally incompetent

• BMI < 16 or BMI > 35

• Allergy to one or more substances of the study medication (= levobupivacaine, dexamethasone, propofol, sufentanil, rocuronium, ketorolac, morphine, ketamine, DHBP, ondansetron, alizapride)

• Chronic strong opioid use (>3 intakes per week)