Spine SurgeryPhase 3EFABENCT04473508
Erectus Nerve Block for Lumbar Spine Surgery
A Phase 3 study testing Local administration of ropivacaine in people with Spine Surgery and Pain Relief, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Surgery, Pain Relief, Morphine
- What is being tested?
- Local administration of ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to 9 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age> 18years and <80 years
- lumbar spine surgery (2-4 levels)
- posterior approach
- ASA 1-3
Who cannot join
- refusal
- age < 18yrs
- <50 kg and >120 kg
- pregnant
- renal or hepatic severe desease
- ASA 4
Show all 12Show fewer
- no French speaking
- emergency surgery
- local or systemic infection
- surgical resumption of the surgical site
- surgery involving a thoracic approach
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study
: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.
- Conditions
- Spine Surgery, Pain Relief, Morphine, AdverseEvent
- Being tested
- Local administration of ropivacaine, Local administration of placebo (saline solution)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local administration of ropivacaineDrug
Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
Local administration of placebo (saline solution)Drug
injection of saline solution in addition with conventional anesthesia for spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL) Receives: Drug: Local administration of ropivacaine |
| Control | Placebo comparator | Local administration of Placebo ( Saline Solution) Receives: Drug: Local administration of placebo (saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption (mg)
Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient
Measured: 24 Hours after surgery
Secondary outcomes (7)
Adverse events
Nausea, vomiting, confusion, urinary retention, hematoma, reintervention
Measured: from surgery to 3 months
pain at rest and at movement: Visual Analogic scale
Visual Analogic scale of pain (0-10)
Measured: Day 1 to Day 3, Day od hospital discharge and month 3
chronic pain: DN4 questionnaire
pain score as mesured with DN4 questionnaire
Measured: Questionnaire DN4 at 3 months
Length of hospital stay
Number of day in hospital
Measured: hospital length of stay, an average of 4 days
Length of stay in the post-intervention care unit
Number of minutes that patient stay in post intervention care unit in minutes
Measured: Day 1
Patient Satisfaction: visual analogic scale
Patient satisfaction mesured with a visual analogic scale (0-10)
Measured: Day of hospital discharge, an average of day 4
Patient Quality of life: EQ-5D Questionnaire
Patient Quality of life mesured with EQ-5D Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start27 Nov 2019
- Primary completion25 Jun 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Avis, Md, Principal investigator, Geoffrey.avis@chu-nimes.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473508
- Sponsor's protocol ID
- LOCAL/2018/PC-02
- Other IDs
- 2019-001678-26, 2019
- Acronym
- EFABE
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avis G, Gricourt Y, Vialatte PB, Meunier V, Perin M, Simon N, Claret PG, El Fertit H, Lefrant JY, Bertrand M, Cuvillon P. Analgesic efficacy of erector spinae plane blocks for lumbar spine surgery: a randomized double-blind controlled clinical trial. Reg Anesth Pain Med. 2022 Jul 21:rapm-2022-103737. doi: 10.1136/rapm-2022-103737. Online ahead of print.
PubMed 35863786
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04473508
- Acronym / sponsor ID
- EFABE / LOCAL/2018/PC-02
- Conditions
- Spine Surgery, Pain Relief, Morphine, AdverseEvent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 16 Jul 2020 (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.
: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Drug: Local administration of ropivacaineactive treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL) |
| Control | Placebo comparator | Drug: Local administration of placebo (saline solution)Local administration of Placebo ( Saline Solution) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age> 18years and <80 years
- lumbar spine surgery (2-4 levels)
- posterior approach
- ASA 1-3
Key exclusion criteria (12 listed)
- refusal
- age < 18yrs
- <50 kg and >120 kg
- pregnant
- renal or hepatic severe desease
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 |
|---|---|---|
| Local administration of ropivacaineErector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery | Drug | Treated |
| Local administration of placebo (saline solution)injection of saline solution in addition with conventional anesthesia for spine surgery | Drug | Control |
Primary outcome
morphine consumption (mg)
Time frame: 24 Hours after surgery
Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient
7 secondary outcomes
Adverse events
Time frame: from surgery to 3 months
pain at rest and at movement: Visual Analogic scale
Time frame: Day 1 to Day 3, Day od hospital discharge and month 3
chronic pain: DN4 questionnaire
Time frame: Questionnaire DN4 at 3 months
Length of hospital stay
Time frame: hospital length of stay, an average of 4 days
Length of stay in the post-intervention care unit
Time frame: Day 1
Patient Satisfaction: visual analogic scale
Time frame: Day of hospital discharge, an average of day 4
Patient Quality of life: EQ-5D Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 35863786Avis G, Gricourt Y, Vialatte PB, Meunier V, Perin M, Simon N, Claret PG, El Fertit H, Lefrant JY, Bertrand M, Cuvillon P. Analgesic efficacy of erector spinae plane blocks for lumbar spine surgery: a randomized double-blind controlled clinical trial. Reg Anesth Pain Med. 2022 Jul 21:rapm-2022-103737. doi: 10.1136/rapm-2022-103737. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Geoffrey Avis, Md principal investigator
Geoffrey.avis@chu-nimes.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Local administration of ropivacaine in people with Spine Surgery and Pain Relief, run by Centre Hospitalier Universitaire de Nīmes 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 4 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: finished, as of the sponsor's last update on 4 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (mg) (time frame: 24 Hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473508, which also lists 1 linked publication.
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 4 Dec 2025.