Pain, Postoperative, SPINAL Fracture
Conditions
Keywords
Erector spinae plane block, Spinal trauma, Percutaneous spinal osteosynthesis
Brief 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.
Interventions
PROCEDUREErector 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
PROCEDUREESPB 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
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption for the first postoperative 24 hours | during the first 24H after the procedure | Morphine consumption for the first postoperative 24 hours(mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative morphine consumption | during the procedure | Post-operative morphic consumption (mg) |
| Evolution of postoperative morphine consumption 1 hour | Post-operative morphic consumption (mg) at postoperative 1 hour | Post-operative morphic consumption (mg) |
| Evolution of postoperative morphine consumption 3 hours | Post-operative morphic consumption (mg) at 3 hours | Post-operative morphic consumption (mg) |
| Evolution of postoperative morphine consumption 6 hours | Post-operative morphic consumption (mg) at 6 hours | Post-operative morphic consumption (mg) |
| Evolution of postoperative morphine consumption 9 hours | Post-operative morphic consumption (mg) at 9 hours | Post-operative morphic consumption (mg) |
| Evolution of postoperative morphine consumption 12 hour | Post-operative morphic consumption (mg) at 12 hours | Post-operative morphic consumption (mg) |
| Evolution of postoperative pain | Every 3 hours during the first 24 hours | Pain evaluation by numerical scale between 0 (none pain) and 10 (worst pain ever) |
| Duration of stay in postanesthesia care unit (PACU) | when two consecutives Aldrete scores at 10 occure | Time (minutes) in PACU ; exit criteria = two consecutives Aldrete scores at 10 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCédric CIRENEI, MD
University Hospital, Lille
Outcome results
None listed