Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures
- Conditions
- SPINAL FracturePain, Postoperative
- Interventions
- Procedure: ESPB with saline 0,9%Procedure: Erector spinae plane block with naropeine [3,75 mg/mL]
- Registration Number
- NCT06200298
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group : ESPB with saline 0,9% ESPB with saline 0,9% - Erector spinae plane block with naropeine [3,75 mg/mL] Erector spinae plane block with naropeine [3,75 mg/mL] Experimental group: Erector spinae plane block with naropeine \[3,75 mg/mL\]
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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 12 hour Post-operative morphic consumption (mg) at 12 hours 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)
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
intraoperative morphine consumption during the procedure 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 9 hours Post-operative morphic consumption (mg) at 9 hours Post-operative morphic consumption (mg)
Trial Locations
- Locations (1)
Hôpital Roger Salengro
🇫🇷Lille, France