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

NCT06200298 | Recruiting

• 2 other identifiers: 2020_12992022-A00358-35
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

Erector spinae plane block; Spinal trauma; Percutaneous spinal osteosynthesis

Outcome Measures

Primary Outcomes (1)

• Morphine consumption for the first postoperative 24 hours

  Morphine consumption for the first postoperative 24 hours(mg)

  during the first 24H after the procedure

Secondary Outcomes (8)

• intraoperative morphine consumption

  during the procedure

• Evolution of postoperative morphine consumption 1 hour

  Post-operative morphic consumption (mg) at postoperative 1 hour

• Evolution of postoperative morphine consumption 3 hours

  Post-operative morphic consumption (mg) at 3 hours

• Evolution of postoperative morphine consumption 6 hours

  Post-operative morphic consumption (mg) at 6 hours

• Evolution of postoperative morphine consumption 9 hours

  Post-operative morphic consumption (mg) at 9 hours

Study Arms (2)

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

EXPERIMENTAL

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

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

Control group : ESPB with saline 0,9%

ACTIVE COMPARATOR

Procedure: ESPB with saline 0,9%

Interventions

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

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

ESPB with saline 0,9% 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

Control group : ESPB with saline 0,9%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Spinal Fractures; Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Cédric CIRENEI, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric CIRENEI, MD

CONTACT

0320445962; cedric.cirenei@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 11, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2023-12

Locations

FR (1)