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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06200298
Other study ID # 2020_1299
Secondary ID 2022-A00358-35
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2024
Est. completion date July 2026

Study information

Verified date December 2023
Source University Hospital, Lille
Contact Cédric CIRENEI, MD
Phone 0320445962
Email cedric.cirenei@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 86
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Procedure:
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
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

Locations

Country Name City State
France Hôpital Roger Salengro Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 intraoperative morphine consumption Post-operative morphic consumption (mg) during the procedure
Secondary Evolution of postoperative morphine consumption 1 hour Post-operative morphic consumption (mg) Post-operative morphic consumption (mg) at postoperative 1 hour
Secondary Evolution of postoperative morphine consumption 3 hours Post-operative morphic consumption (mg) Post-operative morphic consumption (mg) at 3 hours
Secondary Evolution of postoperative morphine consumption 6 hours Post-operative morphic consumption (mg) Post-operative morphic consumption (mg) at 6 hours
Secondary Evolution of postoperative morphine consumption 9 hours Post-operative morphic consumption (mg) Post-operative morphic consumption (mg) at 9 hours
Secondary Evolution of postoperative morphine consumption 12 hour Post-operative morphic consumption (mg) Post-operative morphic consumption (mg) at 12 hours
Secondary Evolution of postoperative pain Pain evaluation by numerical scale between 0 (none pain) and 10 (worst pain ever) Every 3 hours during the first 24 hours
Secondary Duration of stay in postanesthesia care unit (PACU) Time (minutes) in PACU ; exit criteria = two consecutives Aldrete scores at 10 when two consecutives Aldrete scores at 10 occure
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