Clinical trial NCT04925882: Erector Spinae Plane Block in Lumbar Release Surgery
Official title: Erector Spinae Plane Block in Lumbar Release Surgery : Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia Lumbar
Lumbar Canal Stenosis
Spinal Cord Compression
Keywords: Erector spinae plane block
Consumption of morphine
Lead sponsor: Clinique Saint Jean, France
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Consumption of postoperative morphine within 72 hours of the operation
timeFrame: 72 hours
Secondary outcomes:
measure: Digital visual scale to assess pain of patient within 72 hours of the operation.
timeFrame: 72 hours
measure: Onset of nausea and vomiting within 72 hours of the operation.
timeFrame: 72 hours
measure: Onset of complication within 30 days of the operation.
timeFrame: 30 days
measure: Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint Jean
Study officials:
affiliation: Clinique Saint Jean, Saint Jean de Védas
name: Guillaume LONJON, MD
role: PRINCIPAL_INVESTIGATOR
References:
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