NCT06200298

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• SPINAL Fracture
• Pain, Postoperative

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-01-11
• Last updated: 2024-05-16

Locations

1 site across 1 country: France