- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514806
Ultrasound-Guided Erector Spinae Plane Block for Postoperative Pain Control in Lumbar Spondylolisthesis Surgery
Estimation of Intraoperative Anaesthetic Drug Requirement in General Anaesthesia With or Without Erector Spinae Plane Block in Lumbar Spondylolisthesis Surgery
Study Overview
Status
Conditions
Detailed Description
This study is designed as a quasi-experimental trial to investigate the efficacy of the ultrasound-guided erector spinae plane (ESP) block in combination with general anesthesia for postoperative pain management in patients undergoing lumbar spondylolisthesis surgery. This clinical trial will recruit 50 adult patients scheduled for elective lumbar spine surgery, who are assigned to either the intervention or control group.
Intervention Group (Group B): Patients will receive ultrasound-guided ESP block as an adjunct to standard general anesthesia.
Control Group (Group A): Patients will receive general anesthesia without the erector spinae plane (ESP) block.
The trial will evaluate pain control (measured by Visual Analogue Scale [VAS] scores), opioid consumption, and hemodynamic parameters (such as heart rate, blood pressure, and oxygen saturation). Additionally, postoperative recovery quality, the incidence of adverse events, and any potential complications associated with the erector spinae plane (ESP) block will be monitored and compared between groups.
This trial also aims to assess whether the use of the erector spinae plane (ESP) block can reduce opioid consumption, improve hemodynamic stability, and enhance recovery quality in the postoperative period.
The study will be conducted at Bangladesh Medical University (BMU), Dhaka, with all ethical considerations adhered to, and informed consent will be obtained from all participants before enrollment. Participants will be followed for 24 hours post-surgery, with monitoring at several time points to assess the primary and secondary outcomes.
The results of this study are expected to provide valuable insights into the effectiveness of the erector spinae plane (ESP block) in improving surgical outcomes, reducing opioid use, and enhancing recovery after lumbar spine surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dhaka, Bangladesh, 1000
- Bangladesh Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient undergoing lumbar spondylolisthesis surgery.
- Elective procedures.
- Age between 18 to 64 years.
- American Society of Anaesthesiologists (ASA) physical status 1 and 2.
Exclusion Criteria:
- Patient refusal.
- Body Mass Index (BMI) >35 kg/m2
- Coagulopathy or bleeding disorders.
- Allergy to any of the study drugs.
- Substance abuse or dependence or previous history of opioid addiction.
- Patients with central nervous system disease, severe cardiovascular system disease, hepatic disease or renal disease.
- Local infection or inflammation at the site of block placement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Group: General Anesthesia Without Erector Spinae Plane Block
Control Group: General Anesthesia Without Erector Spinae Plane Block In this group, patients will receive standard general anesthesia without the addition of an ultrasound-guided erector spinae plane (ESP) block.
This arm will serve as the comparison group to assess the impact of the ESP block on postoperative pain and recovery outcomes.
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Intervention Type: Drug - General Anesthesia Description: Patients will receive general anesthesia using standard anesthetic agents (e.g., propofol, fentanyl, and isoflurane) without the addition of a regional block.
No erector spinae plane (ESP) block will be performed.
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Experimental: Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block
Intervention Group: General Anaesthesia With Ultrasound-Guided Erector Spinae Plane (ESP) Block In this group, patients will receive general anaesthesia in combination with an ultrasound-guided erector spinae plane block.
The aim is to evaluate whether adding the ESP block improves postoperative pain control, reduces opioid consumption, and enhances hemodynamic stability during and after lumbar spondylolisthesis surgery.
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Description: Patients will receive general anesthesia in combination with an ultrasound-guided erector spinae plane (ESP) block.
The ESP block will be performed at the L3-L5 vertebral level using a 22-gauge needle, with 20 mL of 0.25% bupivacaine and 5 mg dexamethasone administered bilaterally under sterile conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intraoperative Opioid Requirements (Fentanyl in micrograms)
Time Frame: Throughout the duration of surgery.
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The total amount of opioid (fentanyl in microgram) administered during surgery.
The goal is to evaluate the opioid consumption required to maintain adequate analgesia during the procedure.
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Throughout the duration of surgery.
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Intraoperative Inhalational Anaesthetic (Isoflurane in ml/hour) Agent Requirements
Time Frame: Throughout the duration of surgery
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Description: The total consumption of inhalational anesthetic agents (Isoflurane in ml/hour) during the surgical procedure.
This measure will help assess the inhalational anaesthetic requirement between groups.
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Throughout the duration of surgery
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Intraoperative Muscle Relaxant (vecuronium in mg) Requirements
Time Frame: Throughout the duration of surgery
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The total dose of muscle relaxant (vecuronium, in mg) is administered to maintain muscle relaxation during surgery.
This will be compared between the two groups.
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Throughout the duration of surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Intraoperative heart rate (HR)
Time Frame: Recorded at 15-minute intervals during the surgery
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Recorded at 15-minute intervals during the surgery
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Intraoperative Systolic Blood Pressure (mmHg)
Time Frame: Recorded at 15-minute intervals during the surgery
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Recorded at 15-minute intervals during the surgery
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Intraoperative diastolic blood pressure (mmHg)
Time Frame: Recorded at 15-minute intervals during the surgery
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Recorded at 15-minute intervals during the surgery
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Intraoperative Mean Arterial Pressure (mmHg)
Time Frame: Recorded at 15-minute intervals during the surgery
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Recorded at 15-minute intervals during the surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: AKM Akhtaruzzaman, MD, Bangladesh Medical University
Publications and helpful links
General Publications
- Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
- 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.
- Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
- Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
- Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616/asj.2018.0114. Epub 2018 Nov 15.
- Leyva FM, Mendiola WE, Bonilla AJ, Cubillos J, Moreno DA, Chin KJ. Continuous Erector Spinae Plane (ESP) Block for Postoperative Analgesia after Minimally Invasive Mitral Valve Surgery. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2271-2274. doi: 10.1053/j.jvca.2017.12.020. Epub 2017 Dec 12. No abstract available.
- Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
- Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
- Alwardt CM, Redford D, Larson DF. General anesthesia in cardiac surgery: a review of drugs and practices. J Extra Corpor Technol. 2005 Jun;37(2):227-35.
- Brown EN, Pavone KJ, Naranjo M. Multimodal General Anesthesia: Theory and Practice. Anesth Analg. 2018 Nov;127(5):1246-1258. doi: 10.1213/ANE.0000000000003668.
- Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
- Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Kose HC, Kose SG, Thomas DT. Lumbar versus thoracic erector spinae plane block: Similar nomenclature, different mechanism of action. J Clin Anesth. 2018 Aug;48:1. doi: 10.1016/j.jclinane.2018.03.026. Epub 2018 Apr 9. No abstract available.
- 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.
- Ciftci B, Ekinci M, Celik EC, Tukac IC, Bayrak Y, Atalay YO. Efficacy of an Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia Management After Video-Assisted Thoracic Surgery: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):444-449. doi: 10.1053/j.jvca.2019.04.026. Epub 2019 Apr 30.
- Tulgar S, Ahiskalioglu A, De Cassai A, Gurkan Y. Efficacy of bilateral erector spinae plane block in the management of pain: current insights. J Pain Res. 2019 Aug 27;12:2597-2613. doi: 10.2147/JPR.S182128. eCollection 2019.
- Koo CH, Hwang JY, Shin HJ, Ryu JH. The Effects of Erector Spinae Plane Block in Terms of Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 10;9(9):2928. doi: 10.3390/jcm9092928.
- Peker K, Akcaboy ZN, Aydin G, Gencay I, Sahin AT, Kocak YF, Peker SA. The Effect of Erector Spinae Plane Block on Laparoscopic Cholecystectomy Anesthesia: Analysis of Opioid Consumption, Sevoflurane Consumption, and Cost. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):725-729. doi: 10.1089/lap.2019.0809. Epub 2020 Feb 5.
- Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.
- 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.
- Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate spread and nerve involvement between retrolaminar and erector spinae plane blocks in the thoracic region: a cadaveric study. Anaesthesia. 2018 Oct;73(10):1244-1250. doi: 10.1111/anae.14408. Epub 2018 Aug 16.
- Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.
- Neal JM, Barrington MJ, Fettiplace MR, Gitman M, Memtsoudis SG, Morwald EE, Rubin DS, Weinberg G. The Third American Society of Regional Anesthesia and Pain Medicine Practice Advisory on Local Anesthetic Systemic Toxicity: Executive Summary 2017. Reg Anesth Pain Med. 2018 Feb;43(2):113-123. doi: 10.1097/AAP.0000000000000720.
- Rizkalla JM, Holderread B, Awad M, Botros A, Syed IY. The erector spinae plane block for analgesia after lumbar spine surgery: A systematic review. J Orthop. 2021 Feb 18;24:145-150. doi: 10.1016/j.jor.2021.02.006. eCollection 2021 Mar-Apr.
- Abdelnasser A, Zoheir H, Rady A, Ramzy M, Abdelhamid BM. Effectiveness of ultrasound-guided erector spinae plane block for postoperative pain control in hip replacement surgeries; A pilot study. J Clin Anesth. 2020 Jun;62:109732. doi: 10.1016/j.jclinane.2020.109732. Epub 2020 Jan 25. No abstract available.
- Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627. doi: 10.1053/j.jvca.2021.09.034.
- Bryniarski P, Bialka S, Kepinski M, Szelka-Urbanczyk A, Paradysz A, Misiolek H. Erector Spinae Plane Block for Perioperative Analgesia after Percutaneous Nephrolithotomy. Int J Environ Res Public Health. 2021 Mar 31;18(7):3625. doi: 10.3390/ijerph18073625.
- Liang X, Zhou W, Fan Y. Erector spinae plane block for spinal surgery: a systematic review and meta-analysis. Korean J Pain. 2021 Oct 1;34(4):487-500. doi: 10.3344/kjp.2021.34.4.487.
- Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.
- Lucente M, Ragonesi G, Sanguigni M, Sbaraglia F, Vergari A, Lamacchia R, Del Prete D, Rossi M. Erector spinae plane block in children: a narrative review. Korean J Anesthesiol. 2022 Dec;75(6):473-486. doi: 10.4097/kja.22279. Epub 2022 Jul 5.
- Zhang S, Han X, Zhou D, Sun M, Cang J, Miao C, Liang C. The effects of erector spinae plane block on perioperative opioid consumption and rehabilitation in video assisted thoracic surgery. BMC Anesthesiol. 2021 Dec 10;21(1):313. doi: 10.1186/s12871-021-01536-x.
- Wilson AA, Schmid AM, Pestana P Jr, Tubog TD. Erector Spinae Plane Block on Postoperative Pain and Opioid Consumption After Lumbar Spine Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Perianesth Nurs. 2024 Feb;39(1):122-131. doi: 10.1016/j.jopan.2023.06.003. Epub 2023 Sep 23.
- Tulgar S, Thomas DT, Deveci U. Erector spinae plane block provides sufficient surgical anesthesia for ileostomy closure in a high-risk patient. J Clin Anesth. 2018 Aug;48:2-3. doi: 10.1016/j.jclinane.2018.04.001. Epub 2018 Apr 11. No abstract available.
- Sullivan TR, Kanda P, Gagne S, Costache I. Harlequin Syndrome Associated with Erector Spinae Plane Block. Anesthesiology. 2019 Sep;131(3):665. doi: 10.1097/ALN.0000000000002733. No abstract available.
- Soro Domingo M, Belda Nacher FJ, Aguilar Aguilar G, Ferrandis Comes R, Garcia-Raimundo M, Martinez Pons V. [Preoxygenation for anesthesia]. Rev Esp Anestesiol Reanim. 2004 Jun-Jul;51(6):322-7. Spanish.
- Schwartz RH, Urits I, Viswanath O, Urman RD, Kaye AD, Eskander JP. Successful combination of thoracodorsal interfascial plane block and erector spinae pain block for peri-operative pain control after lumbar laminectomy. J Clin Anesth. 2020 Jun;62:109705. doi: 10.1016/j.jclinane.2020.109705. Epub 2020 Jan 11. No abstract available.
- Sachdev D, Mamikunian G, Kia C, Zhou H. Narrative review: erector spinae block in spine surgery. J Spine Surg. 2023 Dec 25;9(4):454-462. doi: 10.21037/jss-23-14. Epub 2023 Dec 20.
- Liao CA, Chen YJ, Shen SJ, Wang QA, Chen SA, Liao CH, Lin JR, Lee CW, Tsai HI. Erector spinae plane block (ESPB) enhances hemodynamic stability decreasing analgesic requirements in surgical stabilization of rib fractures (SSRFs). World J Emerg Surg. 2024 Nov 20;19(1):36. doi: 10.1186/s13017-024-00567-2.
- Kokulu S, Baki ED, Kacar E, Bal A, Senay H, Ustun KD, Yilmaz S, Ela Y, Sivaci RG. Effect of transversus abdominis plane block on cost of laparoscopic cholecystectomy anesthesia. Med Sci Monit. 2014 Dec 23;20:2783-7. doi: 10.12659/MSM.892055.
- Karaca O, Pinar HU. Is high dose lumbar erector spinae plane block safe? J Clin Anesth. 2020 Jun;62:109721. doi: 10.1016/j.jclinane.2020.109721. Epub 2020 Jan 16. No abstract available.
- Hamilton DL, Manickam BP. Is the erector spinae plane (ESP) block a sheath block? Anaesthesia. 2017 Jul;72(7):915-916. doi: 10.1111/anae.13912. No abstract available.
- Elkoundi A, Chouikh C, Baite A, Bensghir M, Bakkali H, Lalaoui SJ. Successful erector spinae plane block without ultrasound guidance in a severely cardiovascular compromised patient. J Clin Anesth. 2019 Mar;53:50. doi: 10.1016/j.jclinane.2018.10.002. Epub 2018 Oct 26. No abstract available.
- De Cassai A, Fasolo A, Geraldini F, Munari M. Motor block following bilateral ESP block. J Clin Anesth. 2020 Mar;60:23. doi: 10.1016/j.jclinane.2019.08.029. Epub 2019 Aug 19. No abstract available.
- De Cassai A, Andreatta G, Bonvicini D, Boscolo A, Munari M, Navalesi P. Injectate spread in ESP block: A review of anatomical investigations. J Clin Anesth. 2020 May;61:109669. doi: 10.1016/j.jclinane.2019.109669. Epub 2019 Nov 26. No abstract available.
- Chung K, Kim ED. Continuous erector spinae plane block at the lower lumbar level in a lower extremity complex regional pain syndrome patient. J Clin Anesth. 2018 Aug;48:30-31. doi: 10.1016/j.jclinane.2018.04.012. Epub 2018 May 1. No abstract available.
- Bydon M, Alvi MA, Goyal A. Degenerative Lumbar Spondylolisthesis: Definition, Natural History, Conservative Management, and Surgical Treatment. Neurosurg Clin N Am. 2019 Jul;30(3):299-304. doi: 10.1016/j.nec.2019.02.003.
- Biro P, Kneschke O, Theusinger OM. Accuracy of calculated volatile agent consumption from fresh gas content. Acta Anaesthesiol Scand. 2015 May;59(5):619-24. doi: 10.1111/aas.12487. Epub 2015 Feb 27.
- Biro P. Calculation of volatile anaesthetics consumption from agent concentration and fresh gas flow. Acta Anaesthesiol Scand. 2014 Sep;58(8):968-72. doi: 10.1111/aas.12374. Epub 2014 Jul 24.
- Barsa M, Filyk O. Erector spinae plane block versus local infiltration anaesthesia for transforaminal percutaneous endoscopic discectomy: A prospective randomised controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Dec;70(10):552-560. doi: 10.1016/j.redare.2022.11.003. Epub 2023 Sep 4.
- Alici HA, Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Celik M. High volume single injection lumbar erector spinae plane block provides effective analgesia for lower extremity herpes zoster. J Clin Anesth. 2019 May;54:136-137. doi: 10.1016/j.jclinane.2018.11.009. Epub 2018 Nov 28. No abstract available.
- Aksu C, Gurkan Y. Aksu approach for lumbar erector spinae plane block for pediatric surgeries. J Clin Anesth. 2019 May;54:74-75. doi: 10.1016/j.jclinane.2018.10.043. Epub 2018 Nov 6. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4975
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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