Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06200298

Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Fracture Back Injuries Fractures, Bone Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with percutaneous arthrodesis spine surgery for fracture
  • Insured persons
  • Age 18 years
  • Being able to receive informed information
  • Have agreed to participate in writing

Exclusion criteria

  • Minor patient
  • Patient refusal
  • Pregnancy
  • Lack of social security coverage
  • Under guardianship or curatorship
  • Inability to express consent
  • History of spinal surgery
  • Unable to use morphine PCA
  • Contraindication to the use of local morphines and/or anesthetics
  • Contraindication to Loco-Regional Anesthesia
  • Long-term opioid patient (Level II and Level III analgesics)
  • 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)

Treatment and study plan

Erector spinae plane block with naropeine [3,75 mg/mL]

Procedure

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

ESPB with saline 0,9%

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. intraoperative morphine consumption

    Time frame: during the procedure

    Post-operative morphic consumption (mg)

  2. Evolution of postoperative morphine consumption 1 hour

    Time frame: Post-operative morphic consumption (mg) at postoperative 1 hour

    Post-operative morphic consumption (mg)

  3. Evolution of postoperative morphine consumption 3 hours

    Time frame: Post-operative morphic consumption (mg) at 3 hours

    Post-operative morphic consumption (mg)

  4. Evolution of postoperative morphine consumption 6 hours

    Time frame: Post-operative morphic consumption (mg) at 6 hours

    Post-operative morphic consumption (mg)

  5. Evolution of postoperative morphine consumption 9 hours

    Time frame: Post-operative morphic consumption (mg) at 9 hours

    Post-operative morphic consumption (mg)

  6. Evolution of postoperative morphine consumption 12 hour

    Time frame: Post-operative morphic consumption (mg) at 12 hours

    Post-operative morphic consumption (mg)

  7. 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)

  8. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: SPINERECTOR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.