Clinical trial NCT06200298: Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures
Official title: Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SPINAL Fracture
Pain, Postoperative
Keywords: Erector spinae plane block
Spinal trauma
Percutaneous spinal osteosynthesis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Morphine consumption for the first postoperative 24 hours
timeFrame: during the first 24H after the procedure
Secondary outcomes:
measure: intraoperative morphine consumption
timeFrame: during the procedure
measure: Evolution of postoperative morphine consumption 1 hour
timeFrame: Post-operative morphic consumption (mg) at postoperative 1 hour
measure: Evolution of postoperative morphine consumption 3 hours
timeFrame: Post-operative morphic consumption (mg) at 3 hours
measure: Evolution of postoperative morphine consumption 6 hours
timeFrame: Post-operative morphic consumption (mg) at 6 hours
measure: Evolution of postoperative morphine consumption 9 hours
timeFrame: Post-operative morphic consumption (mg) at 9 hours
measure: Evolution of postoperative morphine consumption 12 hour
timeFrame: Post-operative morphic consumption (mg) at 12 hours
measure: Evolution of postoperative pain
timeFrame: Every 3 hours during the first 24 hours
measure: Duration of stay in postanesthesia care unit (PACU)
timeFrame: when two consecutives Aldrete scores at 10 occure
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro
Study officials:
affiliation: University Hospital, Lille
name: Cédric CIRENEI, MD
role: PRINCIPAL_INVESTIGATOR
References: