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Erector Spinae Plane Block in Lumbar Spinal Fusion

ConditionLumbar Spinal Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint Jean, France

About this trial

The aim of this study is to observe or not a reduction in the consumption of morphine within 72 hours of the realization of an erector spinae plane block when preparing for a lumbar spinal fusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with medical insurance.

Patient who received information about study and signes a consent to participate in the study.

Major patient requiring a lumbar spinal fusion surgery.

Patient with an ASA score of 1, 2 or 3.

Disqualifiers

Minor patient.

Patient with morphine intolerance

Patient with allergy to local anesthetics.

Patient consuming morphine for more than 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector spinae plane block

    Procedure/Surgery

    Procedure : After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected. Drug : Levobupivacaïne 2,5mg/ml.

  • Erector spinae plane block

    Procedure/Surgery

    Procedure : After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected. Drug : NaCL 0,9%.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: BlockExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Consumption of postoperative morphine within 72 hours of the operation.

Time frame
72 hours

Secondary outcomes

1

Digital visual scale to assess pain of patient within 72 hours of the operation.

Numeric scale numbered from 0 to 10. 0 : no pain, 10: worst pain possible

Time frame
72 hours
2

Onset of nausea and vomiting within 72 hours of the operation.

Onset of nausea/ vomiting or taking an anti-vomiting treatment within 72 hours of the operation.

Time frame
72 hours
3

Onset of complication within 30 days of the intervention.

Time frame
30 days
4

Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.

Measurement of the maximum distance traveled without stopping in meter with or without assistance.

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Saint Jean, France

Lead sponsor

Source ClinicalTrials.gov
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