Erector Spinae Plane Block in Lumbar Release Surgery

Spinal Cord Compression Clinical Trial

— MERLIBERTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925882
• Other study ID #: LOCAL2020-GL02
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: December 19, 2022

Study information

• Verified date: February 2023
• Source: Clinique Saint Jean, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Canal Stenosis
• Spinal Cord Compression

Intervention

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.
• 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 : NaCL 0,9%.

Locations

Country	Name	City	State
France	Clinique Saint Jean	Saint-Jean-de-Védas

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Jean, France

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Nielsen RV, Fomsgaard JS, Dahl JB, Mathiesen O. Insufficient pain management after spine surgery. Dan Med J. 2014 May;61(5):A4835. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of postoperative morphine within 72 hours of the operation		72 hours
Secondary	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
Secondary	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
Secondary	Onset of complication within 30 days of the operation.		30 days
Secondary	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