Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery

NCT ID: NCT06270654

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-01

Brief Summary

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The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery.

Detailed Description

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Most open spine surgery exacts a high degree of postsurgical pain due to the incision and muscle dissection of the vertebra. The postoperative pain control and early mobilization improve the quality of the surgical care. Inadequate pain relief might result in perioperative morbidity, resulting in prolonged hospital stays.

Erector spinae plane block (ESPB) is an interfascial plane block where local anaesthetic is injected in a plane preferably below the erector spinae muscle. It can provide thoracic, abdominal, and even some lower extremity analgesia. It was also theorised that erector spinae plane block can reduce opioid use and provide analgesia for lumbar surgery. The financial cost that is saved by reducing the length of hospital stay, perioperative morbidity will warrant the use of erector spinae plane block in patients undergoing lumbar spine surgery.

Conditions

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Lumbar Spine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Pre incision of 0.375% ropivacaine 10ml local infiltration will be given.

Group Type ACTIVE_COMPARATOR

Skin infiltration LA

Intervention Type PROCEDURE

Pre incision of 0.375% ropivacaine 10ml local infiltration will be given to control group

Ropivacaine group

Bilateral erector spinae plane block (0.375% 20ml ropivacaine on each side + adrenaline 1:200,000) pre incision.

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

After consent was obtained, patients will be randomised into control group and an intervention group. For patients randomized into the interventional group, bilateral erector spinae plane block will be performed under general anaesthesia in prone position before the operation. An experienced anaesthetist performs this under ultrasound guidance (using curvilinear probe) in a sterile method.

After identifying L3 transverse process, 21G Stimuplex needle will be inserted via in-plane method. Once needle placement is confirmed and aspiration is negative, 20ml of ropivacaine 0.375% with adrenaline 1:200,000 dilution will be given on each side.

Interventions

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Erector spinae plane block

After consent was obtained, patients will be randomised into control group and an intervention group. For patients randomized into the interventional group, bilateral erector spinae plane block will be performed under general anaesthesia in prone position before the operation. An experienced anaesthetist performs this under ultrasound guidance (using curvilinear probe) in a sterile method.

After identifying L3 transverse process, 21G Stimuplex needle will be inserted via in-plane method. Once needle placement is confirmed and aspiration is negative, 20ml of ropivacaine 0.375% with adrenaline 1:200,000 dilution will be given on each side.

Intervention Type PROCEDURE

Skin infiltration LA

Pre incision of 0.375% ropivacaine 10ml local infiltration will be given to control group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-75
* Patients with Glasgow Coma Scale of 15.
* American Society of Anaesthesiologists (ASA) Physical Status Classification I - II patients
* Scheduled for elective, open microscopic lumbar surgery (less than 3 levels) under general anesthesia.

Exclusion Criteria

* Cognitive impairment
* Patient refusal
* Weight\<50kg, \>120kg
* Allergy to local anesthesia
* Alcohol/ drug abuse
* Renal failure or liver failure
* Coagulopathy/thrombocytopenia
* Chronic pain with chronic opioid usage
* Ischemic heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universiti Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Facility Contacts

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Wei Keang Tan, M.D.

Role: primary

+60126655489

References

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Siddiqui N, Krishnan S, Dua A, Cascella M. Erector Spinae Plane Block. 2025 May 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545305/

Reference Type BACKGROUND
PMID: 31424889 (View on PubMed)

Donnally III CJ, Hanna A, Varacallo MA. Lumbar Degenerative Disk Disease. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448134/

Reference Type BACKGROUND
PMID: 28846354 (View on PubMed)

Kim HS, Wu PH, Jang IT. Lumbar Degenerative Disease Part 1: Anatomy and Pathophysiology of Intervertebral Discogenic Pain and Radiofrequency Ablation of Basivertebral and Sinuvertebral Nerve Treatment for Chronic Discogenic Back Pain: A Prospective Case Series and Review of Literature. Int J Mol Sci. 2020 Feb 21;21(4):1483. doi: 10.3390/ijms21041483.

Reference Type BACKGROUND
PMID: 32098249 (View on PubMed)

Grotle M, Smastuen MC, Fjeld O, Grovle L, Helgeland J, Storheim K, Solberg TK, Zwart JA. Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway. BMJ Open. 2019 Aug 1;9(8):e028743. doi: 10.1136/bmjopen-2018-028743.

Reference Type BACKGROUND
PMID: 31375617 (View on PubMed)

Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.

Reference Type BACKGROUND
PMID: 26288544 (View on PubMed)

Tan M, Law LS, Gan TJ. Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways. Can J Anaesth. 2015 Feb;62(2):203-18. doi: 10.1007/s12630-014-0275-x. Epub 2014 Dec 10.

Reference Type BACKGROUND
PMID: 25501696 (View on PubMed)

Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

Reference Type BACKGROUND
PMID: 29026331 (View on PubMed)

Jain K, Jaiswal V, Puri A. Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. Indian J Anaesth. 2018 Oct;62(10):809-813. doi: 10.4103/ija.IJA_263_18.

Reference Type BACKGROUND
PMID: 30443066 (View on PubMed)

Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.

Reference Type BACKGROUND
PMID: 30886130 (View on PubMed)

Canitez A, Kozanhan B, Aksoy N, Yildiz M, Tutar MS. Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study. Br J Anaesth. 2021 Oct;127(4):629-635. doi: 10.1016/j.bja.2021.06.030. Epub 2021 Jul 31.

Reference Type BACKGROUND
PMID: 34340839 (View on PubMed)

Vaughan BN, Bartone CL, McCarthy CM, Answini GA, Hurford WE. Ultrasound-Guided Continuous Bilateral Erector Spinae Plane Blocks Are Associated with Reduced Opioid Consumption and Length of Stay for Open Cardiac Surgery: A Retrospective Cohort Study. J Clin Med. 2021 Oct 28;10(21):5022. doi: 10.3390/jcm10215022.

Reference Type BACKGROUND
PMID: 34768541 (View on PubMed)

Lin H, Guan J, Luo S, Chen S, Jiang J. Bilateral Erector Spinae Plane Block for Quality of Recovery Following Posterior Lumbar Interbody Fusion: A Randomized Controlled Trial. Pain Ther. 2022 Sep;11(3):861-871. doi: 10.1007/s40122-022-00395-9. Epub 2022 May 23.

Reference Type BACKGROUND
PMID: 35604613 (View on PubMed)

Jin Y, Zhao S, Cai J, Blessing M, Zhao X, Tan H, Li J. Erector Spinae Plane Block for Perioperative Pain Control and Short-term Outcomes in Lumbar Laminoplasty: A Randomized Clinical Trial. J Pain Res. 2021 Sep 3;14:2717-2727. doi: 10.2147/JPR.S321514. eCollection 2021.

Reference Type BACKGROUND
PMID: 34512011 (View on PubMed)

Zhang TJ, Zhang JJ, Qu ZY, Zhang HY, Qiu Y, Hua Z. Bilateral Erector Spinae Plane Blocks for Open Posterior Lumbar Surgery. J Pain Res. 2020 Apr 5;13:709-717. doi: 10.2147/JPR.S248171. eCollection 2020.

Reference Type BACKGROUND
PMID: 32308470 (View on PubMed)

Bhardwaj N. Enhanced recovery after surgery. J Anaesthesiol Clin Pharmacol. 2019 Apr;35(Suppl 1):S3-S4. doi: 10.4103/joacp.JOACP_57_19. No abstract available.

Reference Type BACKGROUND
PMID: 31142952 (View on PubMed)

Kaye AD, Urman RD, Rappaport Y, Siddaiah H, Cornett EM, Belani K, Salinas OJ, Fox CJ. Multimodal analgesia as an essential part of enhanced recovery protocols in the ambulatory settings. J Anaesthesiol Clin Pharmacol. 2019 Apr;35(Suppl 1):S40-S45. doi: 10.4103/joacp.JOACP_51_18.

Reference Type BACKGROUND
PMID: 31142958 (View on PubMed)

Echeverria-Villalobos M, Stoicea N, Todeschini AB, Fiorda-Diaz J, Uribe AA, Weaver T, Bergese SD. Enhanced Recovery After Surgery (ERAS): A Perspective Review of Postoperative Pain Management Under ERAS Pathways and Its Role on Opioid Crisis in the United States. Clin J Pain. 2020 Mar;36(3):219-226. doi: 10.1097/AJP.0000000000000792.

Reference Type BACKGROUND
PMID: 31868759 (View on PubMed)

Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.

Reference Type BACKGROUND
PMID: 30983590 (View on PubMed)

Avis G, Gricourt Y, Vialatte PB, Meunier V, Perin M, Simon N, Claret PG, El Fertit H, Lefrant JY, Bertrand M, Cuvillon P. Analgesic efficacy of erector spinae plane blocks for lumbar spine surgery: a randomized double-blind controlled clinical trial. Reg Anesth Pain Med. 2022 Jul 21:rapm-2022-103737. doi: 10.1136/rapm-2022-103737. Online ahead of print.

Reference Type BACKGROUND
PMID: 35863786 (View on PubMed)

Other Identifiers

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2023322-12280

Identifier Type: -

Identifier Source: org_study_id

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