Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures

NCT ID: NCT06200298

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2026-07-31

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.

Conditions

SPINAL Fracture; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Erector spinae plane block Procedure:

• Ultrasound scan with protective sleeve and sterile gel. Research of the thoracic spine process between T8 (for thoracic arthrodesis) and T12 (for lumbar arthrodesis)
• Once the thorny process is identified, horizontal shift to the transverse process.
• When the transverse process is spotted, sagittal rotation of the ultrasound probe
• Skin puncture with an 80 mm hyperechogenic needle in the plane of the ultrasound probe. The needle will be placed in contact with the transverse process
• Injection, after aspiration, of the solution prepared blindly by the anesthesiologist performing the procedure. For the ESPB group, a long-acting local anaesthetic: ropivacaine 3.75 mg/mL, 30 mL.
• Repetition of the gesture for the transverse controlateral process

Control group : ESPB with saline 0,9%

Group Type: ACTIVE_COMPARATOR

ESPB with saline 0,9%

Intervention Type: PROCEDURE

Procedure for the Erector spinae plane block Procedure by NaCl 0.9%:

• Ultrasound scan with protective sleeve and sterile gel. Research of the thoracic spine process between T8 (for thoracic arthrodesis) and T12 (for lumbar arthrodesis)
• Once the thorny process is identified, horizontal shift to the transverse process.
• When the transverse process is spotted, sagittal rotation of the ultrasound probe
• Skin puncture with an 80 mm hyperechogenic needle in the plane of the ultrasound probe. The needle will be placed in contact with the transverse process
• Injection, after aspiration, of the solution prepared blindly by the anesthesiologist performing the procedure. For the control group: saline isotonic serum 30 mL.

Repetition of the gesture for the transverse controlateral process

Interventions

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

Erector spinae plane block Procedure:

• Ultrasound scan with protective sleeve and sterile gel. Research of the thoracic spine process between T8 (for thoracic arthrodesis) and T12 (for lumbar arthrodesis)
• Once the thorny process is identified, horizontal shift to the transverse process.
• When the transverse process is spotted, sagittal rotation of the ultrasound probe
• Skin puncture with an 80 mm hyperechogenic needle in the plane of the ultrasound probe. The needle will be placed in contact with the transverse process
• Injection, after aspiration, of the solution prepared blindly by the anesthesiologist performing the procedure. For the ESPB group, a long-acting local anaesthetic: ropivacaine 3.75 mg/mL, 30 mL.
• Repetition of the gesture for the transverse controlateral process

Intervention Type: PROCEDURE

ESPB with saline 0,9%

Procedure for the Erector spinae plane block Procedure by NaCl 0.9%:

• Ultrasound scan with protective sleeve and sterile gel. Research of the thoracic spine process between T8 (for thoracic arthrodesis) and T12 (for lumbar arthrodesis)
• Once the thorny process is identified, horizontal shift to the transverse process.
• When the transverse process is spotted, sagittal rotation of the ultrasound probe
• Skin puncture with an 80 mm hyperechogenic needle in the plane of the ultrasound probe. The needle will be placed in contact with the transverse process
• Injection, after aspiration, of the solution prepared blindly by the anesthesiologist performing the procedure. For the control group: saline isotonic serum 30 mL.

Repetition of the gesture for the transverse controlateral process

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cédric CIRENEI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Roger Salengro

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cédric CIRENEI, MD

Role: CONTACT

cedric.cirenei@chru-lille.fr

0320445962

Facility Contacts

Cédric Cirenei, M.D.

Role: primary

cedric.cirenei@chu-lille.fr

Other Identifiers

2022-A00358-35

Identifier Type: OTHER

Identifier Source: secondary_id

2020_1299

Identifier Type: -

Identifier Source: org_study_id