An interventional study of Erector spinae plane block and Erector spinae plane block in Hernia Lumbar, Lumbar Canal Stenosis and Spinal Cord Compression, sponsored by Clinique Saint Jean, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Clinique Saint Jean, France · Not applicable, Interventional, and Treatment
The aim of this study is to observe or not a reduction in the consumption of morphine within 72 hours of the realization of an erector spinae plane block when preparing for a non-instrumented spine surgery.
Posterior lumbar spine surgery is surgery described by patients as painful. While fusion surgery seems more painful than simple release surgery, release surgery remains a painful surgery for patients. The management of post-operative pain is therefore a priority for anesthesiological-surgical teams.
Multimodal analgesia, already recognized for other surgeries, is one of the keys to success, combining oral analgesics and regional local anesthetics.
The recourse to the realization of a block of the erector muscles of the spine was described for the first time in 2016, it is described there in the literature as not presenting any particular risk, simple to apply and having a satisfactory analgesia action. However, this process is little described in the context of spine surgery and even less in the context of randomized controlled trials.
The investigator therefore hypothesize that the realization of a block of the erector muscles of the spine, because of its satisfactory analgesia action mentioned above, will decrease the consumption of postoperative morphine and at the same time reduce the side effects due to the latter.
On the other hand, no study has evaluated the effectiveness of spinal block as part of an Enhanced Rehabilitation After Surgery (RAAC) program. Indeed, the effectiveness of this practice has already been proven in a context of conventional care, but to date no studies have been carried out in the context of care involving the original elements of the RAAC, such as rapid mobilization and multimodal oral analgesia, which could impact the effectiveness of the erector muscle blocks of the spine.
At the Clinique Saint Jean Sud de France, the management of spine surgeries is part of this Improved Rehabilitation After Surgery (RAAC) process, which is why it seemed relevant to the investigator to carry out a randomized, controlled study. , double-blind to assess the consumption of postoperative morphine during the 72 hours following a lumbar arthrodesis in this context of care.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's enrollment of 100 is above the median of 43 across 35 interventional studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →Clinique Saint Jean, France is the lead sponsor of 15 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The "Block" group will be made up of patients who will benefit from an injection of levopubivacaïne for the realization of the erector spinae plane block.
Procedure: Erector spinae plane block
The "Placebo" group corresponds to the reference group, that is to say that it will consist of patients who benefit from an injection of physiological serum for the realization of the erector spinae plane block.
Procedure: Erector spinae plane block
After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected. Drug : Levobupivacaïne 2,5mg/ml.
After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected. Drug : NaCL 0,9%.
Consumption of postoperative morphine within 72 hours of the operation
Time frame: 72 hours
Digital visual scale to assess pain of patient within 72 hours of the operation.
Numeric scale numbered from 0 to 10. 0 : no pain, 10 : worst pain possible.
Time frame: 72 hours
Onset of nausea and vomiting within 72 hours of the operation.
Onset of nausea/vomiting or taking an anti-vomiting treatment within 72 hours of the operation.
Time frame: 72 hours
Onset of complication within 30 days of the operation.
Time frame: 30 days
Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.
Measurement of the maximum distance traveled without stopping in meter with or without assistance.
Time frame: 72 hours
Ran from Jan 2022 to primary completion in Dec 2022, 11 months.
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Clinique Saint Jean, France