Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures (SPINERECTOR)

May 11, 2026 updated by: University Hospital, Lille

Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures: a Randomized Controlled Trial

Spinal fracture surgery is a common surgery. Post-operative pain has been reduced by the advent of so-called minimally invasive techniques. The immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma.

The erector spinae plane block (ESPB) is a loco-regional anesthesia technique first described in 2016.

A retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use.

In order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study.

The objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. The expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Hôpital Roger Salengro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with percutaneous arthrodesis spine surgery for fracture
  2. Insured persons
  3. Age 18 years
  4. Being able to receive informed information
  5. Have agreed to participate in writing

Exclusion Criteria:

  1. Minor patient
  2. Patient refusal
  3. Pregnancy
  4. Lack of social security coverage
  5. Under guardianship or curatorship
  6. Inability to express consent
  7. History of spinal surgery
  8. Unable to use morphine PCA
  9. Contraindication to the use of local morphines and/or anesthetics
  10. Contraindication to Loco-Regional Anesthesia
  11. Long-term opioid patient (Level II and Level III analgesics)
  12. Patient with preoperative neuropathic pain (score greater than or equal to 4 on the DN4 questionnaire or taking anti-epileptic or anti-depressant treatments for neuropathic pain)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector spinae plane block with naropeine [3,75 mg/mL]
Experimental group: Erector spinae plane block with naropeine [3,75 mg/mL]
Procedure: Erector spinae plane block with naropeine [3,75 mg/mL]

Erector spinae plane block Procedure:

  • Ultrasound scan with protective sleeve and sterile gel. Research of the thoracic spine process between T8 (for thoracic arthrodesis) and T12 (for lumbar arthrodesis)
  • Once the thorny process is identified, horizontal shift to the transverse process.
  • When the transverse process is spotted, sagittal rotation of the ultrasound probe
  • Skin puncture with an 80 mm hyperechogenic needle in the plane of the ultrasound probe. The needle will be placed in contact with the transverse process
  • Injection, after aspiration, of the solution prepared blindly by the anesthesiologist performing the procedure. For the ESPB group, a long-acting local anaesthetic: ropivacaine 3.75 mg/mL, 30 mL.
  • Repetition of the gesture for the transverse controlateral process
Active Comparator: Control group : ESPB with saline 0,9%
Procedure: ESPB with saline 0,9%

Procedure for the Erector spinae plane block Procedure by NaCl 0.9%:

  • Ultrasound scan with protective sleeve and sterile gel. Research of the thoracic spine process between T8 (for thoracic arthrodesis) and T12 (for lumbar arthrodesis)
  • Once the thorny process is identified, horizontal shift to the transverse process.
  • When the transverse process is spotted, sagittal rotation of the ultrasound probe
  • Skin puncture with an 80 mm hyperechogenic needle in the plane of the ultrasound probe. The needle will be placed in contact with the transverse process
  • Injection, after aspiration, of the solution prepared blindly by the anesthesiologist performing the procedure. For the control group: saline isotonic serum 30 mL.

Repetition of the gesture for the transverse controlateral process

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption for the first postoperative 24 hours
Time Frame: during the first 24H after the procedure
Morphine consumption for the first postoperative 24 hours(mg)
during the first 24H after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative morphine consumption
Time Frame: during the procedure
Post-operative morphic consumption (mg)
during the procedure
Evolution of postoperative morphine consumption 1 hour
Time Frame: Post-operative morphic consumption (mg) at postoperative 1 hour
Post-operative morphic consumption (mg)
Post-operative morphic consumption (mg) at postoperative 1 hour
Evolution of postoperative morphine consumption 3 hours
Time Frame: Post-operative morphic consumption (mg) at 3 hours
Post-operative morphic consumption (mg)
Post-operative morphic consumption (mg) at 3 hours
Evolution of postoperative morphine consumption 6 hours
Time Frame: Post-operative morphic consumption (mg) at 6 hours
Post-operative morphic consumption (mg)
Post-operative morphic consumption (mg) at 6 hours
Evolution of postoperative morphine consumption 9 hours
Time Frame: Post-operative morphic consumption (mg) at 9 hours
Post-operative morphic consumption (mg)
Post-operative morphic consumption (mg) at 9 hours
Evolution of postoperative morphine consumption 12 hour
Time Frame: Post-operative morphic consumption (mg) at 12 hours
Post-operative morphic consumption (mg)
Post-operative morphic consumption (mg) at 12 hours
Evolution of postoperative pain
Time Frame: Every 3 hours during the first 24 hours
Pain evaluation by numerical scale between 0 (none pain) and 10 (worst pain ever)
Every 3 hours during the first 24 hours
Duration of stay in postanesthesia care unit (PACU)
Time Frame: when two consecutives Aldrete scores at 10 occure
Time (minutes) in PACU ; exit criteria = two consecutives Aldrete scores at 10
when two consecutives Aldrete scores at 10 occure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Cédric CIRENEI, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Actual)

April 25, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_1299
  • 2022-A00358-35 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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