search
Back to results

Erector Spinae Plane Block in Lumbar Release Surgery (MERLIBERTION)

Primary Purpose

Hernia Lumbar, Lumbar Canal Stenosis, Spinal Cord Compression

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Erector spinae plane block
Erector spinae plane block
Sponsored by
Clinique Saint Jean, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia Lumbar focused on measuring Erector spinae plane block, Consumption of morphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique Saint JeanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Block

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Consumption of postoperative morphine within 72 hours of the operation

Secondary Outcome Measures

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.
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.
Onset of complication within 30 days of the operation.
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.

Full Information

First Posted
June 8, 2021
Last Updated
February 8, 2023
Sponsor
Clinique Saint Jean, France
search

1. Study Identification

Unique Protocol Identification Number
NCT04925882
Brief Title
Erector Spinae Plane Block in Lumbar Release Surgery
Acronym
MERLIBERTION
Official Title
Erector Spinae Plane Block in Lumbar Release Surgery : Double-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
January 6, 2024 (Anticipated)
Study Completion Date
February 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Saint Jean, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia Lumbar, Lumbar Canal Stenosis, Spinal Cord Compression
Keywords
Erector spinae plane block, Consumption of morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Consumption of postoperative morphine within 72 hours of the operation
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Digital visual scale to assess pain of patient within 72 hours of the operation.
Description
Numeric scale numbered from 0 to 10. 0 : no pain, 10 : worst pain possible.
Time Frame
72 hours
Title
Onset of nausea and vomiting within 72 hours of the operation.
Description
Onset of nausea/vomiting or taking an anti-vomiting treatment within 72 hours of the operation.
Time Frame
72 hours
Title
Onset of complication within 30 days of the operation.
Time Frame
30 days
Title
Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.
Description
Measurement of the maximum distance traveled without stopping in meter with or without assistance.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie SOULIER
Phone
04 67 61 20 71
Ext
+33
Email
julie.soulier@capsante.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume LONJON, MD
Organizational Affiliation
Clinique Saint Jean, Saint Jean de Védas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Jean
City
Saint-Jean-de-Védas
ZIP/Postal Code
34430
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie SOULIER
Phone
04 67 61 20 71
Ext
+33
Email
julie.soulier@capsante.fr
First Name & Middle Initial & Last Name & Degree
Guillaume LONJON, MD
First Name & Middle Initial & Last Name & Degree
Aurélien BONNAL, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31681518
Citation
Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019.
Results Reference
background
PubMed Identifier
31083198
Citation
Ren Z, Li Z, Li S, Sheng L, Xu D, Chen X, Wu WKK, Chan MTV, Ho J. Local infiltration with cocktail analgesics during 2 level lumbar spinal fusion surgery: Study protocol of a randomized controlled trial. Medicine (Baltimore). 2019 May;98(19):e15526. doi: 10.1097/MD.0000000000015526.
Results Reference
background
PubMed Identifier
31315670
Citation
Breebaart MB, Van Aken D, De Fre O, Sermeus L, Kamerling N, de Jong L, Michielsen J, Roelant E, Saldien V, Versyck B. A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery. Trials. 2019 Jul 17;20(1):441. doi: 10.1186/s13063-019-3541-y.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
32669870
Citation
Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
Results Reference
background
PubMed Identifier
30743153
Citation
Ince I, Atalay C, Ozmen O, Ozturk V, Hassan M, Aksoy M, Calikoglu C. Comparison of ultrasound-guided thoracolumbar interfascial plane block versus wound infiltration for postoperative analgesia after single-level discectomy. J Clin Anesth. 2019 Sep;56:113-114. doi: 10.1016/j.jclinane.2019.01.017. Epub 2019 Feb 8. No abstract available.
Results Reference
background
PubMed Identifier
30680264
Citation
Cesur S, Yayik AM, Ozturk F, Ahiskalioglu A. Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. Cureus. 2018 Nov 16;10(11):e3603. doi: 10.7759/cureus.3603.
Results Reference
background
PubMed Identifier
23681498
Citation
Mathiesen O, Dahl B, Thomsen BA, Kitter B, Sonne N, Dahl JB, Kehlet H. A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery. Eur Spine J. 2013 Sep;22(9):2089-96. doi: 10.1007/s00586-013-2826-1. Epub 2013 May 17.
Results Reference
background
PubMed Identifier
15247111
Citation
Davies AF, Segar EP, Murdoch J, Wright DE, Wilson IH. Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Br J Anaesth. 2004 Sep;93(3):368-74. doi: 10.1093/bja/aeh224. Epub 2004 Jul 9.
Results Reference
background
PubMed Identifier
28913452
Citation
Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.
Results Reference
background
PubMed Identifier
30292068
Citation
Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
Results Reference
background
PubMed Identifier
32357842
Citation
Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.
Results Reference
background
PubMed Identifier
24814741
Citation
Nielsen RV, Fomsgaard JS, Dahl JB, Mathiesen O. Insufficient pain management after spine surgery. Dan Med J. 2014 May;61(5):A4835.
Results Reference
background
PubMed Identifier
23392233
Citation
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Results Reference
background

Learn more about this trial

Erector Spinae Plane Block in Lumbar Release Surgery

We'll reach out to this number within 24 hrs