Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures (SPINERECTOR)

University Hospital, Lille

Status: Enrolling

Conditions: SPINAL Fracture; Pain, Postoperative

Treatments: Procedure: Erector spinae plane block with naropeine [3,75 mg/mL]; Procedure: ESPB with saline 0,9%

Study type: Interventional

Funder types: Other

Identifiers

NCT06200298

2022-A00358-35 (Other Identifier)

2020_1299

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups

Erector spinae plane block with naropeine [3,75 mg/mL]

Experimental group

Description:

Experimental group: Erector spinae plane block with naropeine \[3,75 mg/mL\]

Treatment:

Procedure: Erector spinae plane block with naropeine [3,75 mg/mL]

Control group : ESPB with saline 0,9%

Active Comparator group

Treatment:

Procedure: ESPB with saline 0,9%