Lumbar Erector Spinae Plane Block for Back Surgery

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

Conditions

• Pain, Postoperative
• Anaesthesia
• Surgery
• Nerve Block
• Anesthesia, Local
• Back Pain
• Spinal Fusion

Interventions

PROCEDURE

Erector spinae plane block

Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle

DRUG

Levobupivacaine 0,25%

20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle

PROCEDURE

spine fusion

fusion of lumbar vertebral body on 1 or two levels

DRUG

NaCL 0,9%

20 ml solution used for the infiltration between the transverse process and th erector spinal muscle

DRUG

Sufentanil

opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)

DRUG

propofol

induction agent for general anaesthesia ( 2-3 mg/kg)

DRUG

Rocuronium Bromide

muscle relaxant used during general anaesthesia ( 0,5 mg/kg)

DRUG

sevoflurane

inhalation aesthetic used for the maintenance of general anaesthesia

DRUG

paracetamol

postoperative drug for analgesia ( 1 gram 4/day)

DRUG

Ketorolac

non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)

DRUG

morphine pca

postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml

DRUG

Dexamethasone

drug given during general anaesthesia to prevent postoperative nausea

DRUG

Morphine

loading dose morhine 0,1 mg/kg at the end of surgery

Sponsors & Collaborators

• Dr M. B. Breebaart

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2023-12-15

Completion

2023-12-15

Countries

• Belgium

Study Locations