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Lumbar Spine DiseaseNCT06270654

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

A study testing Erector spinae plane block and Skin infiltration LA in people with Lumbar Spine Disease, run by University of Malaya at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lumbar Spine Disease
What is being tested?
Erector spinae plane block and Skin infiltration LA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteMalaysia
Study dates
1 Jun 2023to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Cognitive impairment
  • Patient refusal
  • Weight<50kg, >120kg
  • Allergy to local anesthesia
  • Alcohol/ drug abuse
  • Renal failure or liver failure
Show all 9Show fewer
  • Coagulopathy/thrombocytopenia
  • Chronic pain with chronic opioid usage
  • Ischemic heart disease

Trial locations and contacts

1 site in 1 country.

Malaysia1 site, 1 recruiting

  • Universiti Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 51100

    Wei Keang Tan, M.D., +60126655489, weikeang@ummc.edu.my

    Wei Keang Tan, MD.

    Recruiting

Other trials in Malaysia

About this study

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.

Read the detailed description

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.

Being tested
Erector spinae plane block, Skin infiltration LA
Medical subject headings
Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector spinae plane blockProcedure or surgery

    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.

  • Skin infiltration LAProcedure or surgery

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

Study groups in NCT06270654
Study groupRoleWhat they receive
Control groupActive comparatorPre incision of 0.375% ropivacaine 10ml local infiltration will be given.
Receives: Procedure: Skin infiltration LA
Ropivacaine groupExperimentalBilateral erector spinae plane block (0.375% 20ml ropivacaine on each side + adrenaline 1:200,000) pre incision.
Receives: Procedure: Erector spinae plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 24 hours

  2. Total opioid consumption intraoperative

    Measure by total dose consumed (in milligram)

    Measured: 48 hours

  3. Total opioid consumption post-operative

    Measure by total dose consumed (in milligram)

    Measured: up to 72 hours

  4. Timing of first rescue dose of iv morphine

    Post operation till time requiring first dose of iv morphine

    Measured: up to 24 hours

Secondary outcomes (5)

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

    Measure by the quality of recovery score (QoR)-15 questionnaire (minimum of 0,maximum of 150,higher score means a better outcome)

    Measured: 24 hours

  2. Hemodynamic changes intraoperative

    Blood pressure(measure in mm hg)

    Measured: Intraoperative period

  3. Hemodynamic changes intraoperative

    heart rate (heart rate measure via heart beats per minute/ECG)

    Measured: Intraoperative period

  4. Length of hospital stays

    Days of stay in hospital

    Measured: up to 1 week

  5. Time to ambulation after surgery

    Time from operation till ambulation

    Measured: up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start1 Jun 2023
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06270654
Sponsor's protocol ID
2023322-12280
Status last verified
Feb 2024
First submitted
28 Aug 2023
Last updated
21 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siddiqui N, Krishnan S, Dua A, Cascella M. Erector Spinae Plane Block. 2025 May 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545305/

    PubMed 31424889

  • Donnally III CJ, Hanna A, Varacallo M. Lumbar Degenerative Disk Disease. [Updated 2023 Jan 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK448134/

  • 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.

    PubMed 32098249

  • 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.

    PubMed 31375617

  • 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.

    PubMed 26288544

  • 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.

    PubMed 25501696

  • 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.

    PubMed 29026331

  • 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.

    PubMed 30443066

  • 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.

    PubMed 30886130

  • 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.

    PubMed 34340839

  • 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.

    PubMed 34768541

  • 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.

    PubMed 35604613

  • 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.

    PubMed 34512011

  • 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.

    PubMed 32308470

  • 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.

    PubMed 31142952

Questions about this trial

What is this clinical trial studying?

A study testing Erector spinae plane block and Skin infiltration LA in people with Lumbar Spine Disease, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06270654, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.

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