Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- SPINAL Fracture
- Sponsor
- University Hospital, Lille
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Morphine consumption for the first postoperative 24 hours
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Minor patient
- •Patient refusal
- •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)
Outcomes
Primary Outcomes
Morphine consumption for the first postoperative 24 hours
Time Frame: during the first 24H after the procedure
Morphine consumption for the first postoperative 24 hours(mg)
Secondary Outcomes
- Evolution of postoperative pain(Every 3 hours during the first 24 hours)
- Evolution of postoperative morphine consumption 6 hours(Post-operative morphic consumption (mg) at 6 hours)
- Evolution of postoperative morphine consumption 12 hour(Post-operative morphic consumption (mg) at 12 hours)
- Evolution of postoperative morphine consumption 1 hour(Post-operative morphic consumption (mg) at postoperative 1 hour)
- Duration of stay in postanesthesia care unit (PACU)(when two consecutives Aldrete scores at 10 occure)
- intraoperative morphine consumption(during the procedure)
- Evolution of postoperative morphine consumption 3 hours(Post-operative morphic consumption (mg) at 3 hours)
- Evolution of postoperative morphine consumption 9 hours(Post-operative morphic consumption (mg) at 9 hours)