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

Pain, Postoperative Clinical Trial

— SPINERECTOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200298
• Other study ID #: 2020_1299
• Secondary ID: 2022-A00358-35
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: July 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Lille
• Contact: Cédric CIRENEI, MD
• Phone: 0320445962
• Email: cedric.cirenei[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Pain, Postoperative
• SPINAL Fracture
• Spinal Fractures

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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