SPINAL FractureSPINERECTORNCT06200298
Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures
A study testing Erector spinae plane block with naropeine [3,75 mg/mL] and ESPB with saline 0,9% in people with SPINAL Fracture and Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SPINAL Fracture, Pain, Postoperative
- What is being tested?
- Erector spinae plane block with naropeine [3,75 mg/mL] and ESPB with saline 0,9%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minor patient
- Patient refusal
- Pregnancy
- Lack of social security coverage
- Under guardianship or curatorship
- Inability to express consent
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures: a Randomized Controlled Trial
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.
Read more
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
- Being tested
- Erector spinae plane block with naropeine [3,75 mg/mL], ESPB with saline 0,9%
- Keywords
- Erector spinae plane block, Spinal trauma, Percutaneous spinal osteosynthesis
- Medical subject headings
- Spinal Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block with naropeine [3,75 mg/mL]Procedure or surgery
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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block with naropeine [3,75 mg/mL] | Experimental | Experimental group: Erector spinae plane block with naropeine [3,75 mg/mL] Receives: Procedure: Erector spinae plane block with naropeine [3,75 mg/mL] |
| Control group : ESPB with saline 0,9% | Active comparator | Not described Receives: Procedure: ESPB with saline 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption for the first postoperative 24 hours
Morphine consumption for the first postoperative 24 hours(mg)
Measured: during the first 24H after the procedure
Secondary outcomes (8)
intraoperative morphine consumption
Post-operative morphic consumption (mg)
Measured: during the procedure
Evolution of postoperative morphine consumption 1 hour
Post-operative morphic consumption (mg)
Measured: Post-operative morphic consumption (mg) at postoperative 1 hour
Evolution of postoperative morphine consumption 3 hours
Post-operative morphic consumption (mg)
Measured: Post-operative morphic consumption (mg) at 3 hours
Evolution of postoperative morphine consumption 6 hours
Post-operative morphic consumption (mg)
Measured: Post-operative morphic consumption (mg) at 6 hours
Evolution of postoperative morphine consumption 9 hours
Post-operative morphic consumption (mg)
Measured: Post-operative morphic consumption (mg) at 9 hours
Evolution of postoperative morphine consumption 12 hour
Post-operative morphic consumption (mg)
Measured: Post-operative morphic consumption (mg) at 12 hours
Evolution of postoperative pain
Pain evaluation by numerical scale between 0 (none pain) and 10 (worst pain ever)
Measured: Every 3 hours during the first 24 hours
Duration of stay in postanesthesia care unit (PACU)
Time (minutes) in PACU ; exit criteria = two consecutives Aldrete scores at 10
Measured: when two consecutives Aldrete scores at 10 occure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start11 Apr 2024
- Primary completion25 Apr 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPINAL FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric CIRENEI, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200298
- Sponsor's protocol ID
- 2020_1299
- Other IDs
- 2022-A00358-35
- Acronym
- SPINERECTOR
- Status last verified
- May 2026
- First submitted
- 11 Dec 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06200298
- Acronym / sponsor ID
- SPINERECTOR / 2020_1299
- Conditions
- SPINAL Fracture, Pain, Postoperative
- Keywords
- Erector spinae plane block, Spinal trauma, Percutaneous spinal osteosynthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block with naropeine [3,75 mg/mL] | Experimental | Procedure: Erector spinae plane block with naropeine [3,75 mg/mL]Experimental group: 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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Minor patient
- Patient refusal
- Pregnancy
- Lack of social security coverage
- Under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Erector spinae plane block with naropeine [3,75 mg/mL] |
| 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 | Procedure or surgery | Control group : ESPB with saline 0,9% |
Primary outcome
Morphine consumption for the first postoperative 24 hours
Time frame: during the first 24H after the procedure
Morphine consumption for the first postoperative 24 hours(mg)
8 secondary outcomes
intraoperative morphine consumption
Time frame: during the procedure
Evolution of postoperative morphine consumption 1 hour
Time frame: Post-operative morphic consumption (mg) at postoperative 1 hour
Evolution of postoperative morphine consumption 3 hours
Time frame: Post-operative morphic consumption (mg) at 3 hours
Evolution of postoperative morphine consumption 6 hours
Time frame: Post-operative morphic consumption (mg) at 6 hours
Evolution of postoperative morphine consumption 9 hours
Time frame: Post-operative morphic consumption (mg) at 9 hours
Evolution of postoperative morphine consumption 12 hour
Time frame: Post-operative morphic consumption (mg) at 12 hours
Evolution of postoperative pain
Time frame: Every 3 hours during the first 24 hours
Duration of stay in postanesthesia care unit (PACU)
Time frame: when two consecutives Aldrete scores at 10 occure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric CIRENEI, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block with naropeine [3,75 mg/mL] and ESPB with saline 0,9% in people with SPINAL Fracture and Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption for the first postoperative 24 hours (time frame: during the first 24H after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.