NCT06270654

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

August 28, 2023

Last Update Submit

February 13, 2024

Conditions

Lumbar Spine Disease

Outcome Measures

Primary Outcomes (4)

  • Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery

    Measure by numerical rating scale (minimum 1-least pain, maximum 10-most painful)

    24 hours

  • Total opioid consumption intraoperative

    Measure by total dose consumed (in milligram)

    48 hours

  • Total opioid consumption post-operative

    Measure by total dose consumed (in milligram)

    up to 72 hours

  • Timing of first rescue dose of iv morphine

    Post operation till time requiring first dose of iv morphine

    up to 24 hours

Secondary Outcomes (5)

  • The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation

    24 hours

  • Hemodynamic changes intraoperative

    Intraoperative period

  • Hemodynamic changes intraoperative

    Intraoperative period

  • Length of hospital stays

    up to 1 week

  • Time to ambulation after surgery

    up to 1 week

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Procedure: Skin infiltration LA

Ropivacaine group

EXPERIMENTAL

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

Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

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.

Ropivacaine group
Skin infiltration LAPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 51100, Malaysia

RECRUITING

Related Publications (19)

  • 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/

    PMID: 31424889BACKGROUND

  • 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/

    PMID: 28846354BACKGROUND

  • 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.

    PMID: 32098249BACKGROUND

  • 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.

    PMID: 31375617BACKGROUND

  • 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.

    PMID: 26288544BACKGROUND

  • 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.

    PMID: 25501696BACKGROUND

  • 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.

    PMID: 29026331BACKGROUND

  • 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.

    PMID: 30443066BACKGROUND

  • 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.

    PMID: 30886130BACKGROUND

  • 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.

    PMID: 34340839BACKGROUND

  • 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.

    PMID: 34768541BACKGROUND

  • 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.

    PMID: 35604613BACKGROUND

  • 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.

    PMID: 34512011BACKGROUND

  • 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.

    PMID: 32308470BACKGROUND

  • 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.

    PMID: 31142952BACKGROUND

  • 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.

    PMID: 31142958BACKGROUND

  • 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.

    PMID: 31868759BACKGROUND

  • 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.

    PMID: 30983590BACKGROUND

  • 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.

    PMID: 35863786BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

February 21, 2024

Study Start

June 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)