Pain, Postoperative Clinical Trial
— SPINERECTOROfficial title:
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Roger Salengro | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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 |
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