Erector Spinae Plane Block in Lumbar Release Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Erector Spinae Plane Block in Lumbar Release Surgery : Double-blind, Randomized Controlled Trial

Conditions
-----------------
Hernia Lumbar, Lumbar Canal Stenosis, Spinal Cord Compression

Intervention / Treatment
-----------------
* Procedure: Erector spinae plane block
* Procedure: Erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with medical insurance. Patient twho received information about study and signes a consent to participate in the study. Major patient to be operated on for lumbar release surgery without arthrodesis or osteosynthesis posterior (herniated disc repair, one or two level recalibration, laminectomy) +/- implant interlaminar. Patient with an ASA score of 1, 2 or 3. Exclusion Criteria: Minor patient. Patient with morphine intolerance Patient with allergy to local anesthetics. Patient consuming morphine for more than 3 months. Pregnant or breastfeeding patient. Patient scheduled for cancer surgery or trauma surgery. Patient participating in another interventional study. Patient with a history of lumbar arthrodesis. Patient requiring lumbar surgery with arthrodesis. Patient refusing to sign the consent form. Patient for whom it is impossible to give informed information. Patient under the protection of justice, under curatorship or under tutorship.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Block<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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<br>* 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%.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of postoperative morphine within 72 hours of the operation |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 72 hours | 
| Onset of complication within 30 days of the operation. |  | 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. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector spinae plane block, Consumption of morphine