GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries
NCT ID: NCT05444751
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
PHASE3
142 participants
INTERVENTIONAL
2022-03-22
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery
NCT05494125
Effect of Erector Spinae (ESP) Block on Opioid Reduction and Enhanced Recovery After Posterior Cervical Spine Surgery
NCT04646707
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
NCT04156581
Erector Spinae Block for Spine Surgery
NCT05417113
Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries
NCT05664542
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subsequent studies have consistently concluded that SA is associated with shorter surgical duration and less blood loss in patients compared to GA for spine surgery. Additionally, hospital length of stay has been reported to be shorter after SA, perhaps due to lower incidence of complications found in several series.
Early postoperative pain control may also be superior after SA in patients undergoing microdiscectomy, attributed to residual sensory block after SA. In addition to higher peaks in pain scores and significantly greater analgesic requirements among the GA group, more episodes of nausea were described, and more antiemetic medications were given.
Intraoperative neurophysiological monitoring (IONM) during procedures such as one and two-level microdiscectomies and laminotomies, use somatosensory evoked potentials (SSEPs), motor evoked potentials (MEPs), and electromyograms (EMGs) as routine during surgery. Surgeons can monitor spinal cord and nerve root function in real-time, take measures to prevent/lessen irritation or potential damage and can detect intraoperative neurologic injuries. Microdiscectomies and laminotomies are one of the most common spinal procedures, which can be performed in both its "open" and "minimally invasive" variations, is a well-established, safe procedure. However, studies have shown that the use of IONM in smaller, less complicated procedures such as microdiscectomies or laminotomies, may add to the overall cost without providing many benefits. Decompressive surgeries under SA cover only the spine and nerve roots within a specific region. Subsequently, SA does not transmit sensory impulses to the brain, therefore, neuromonitoring such as somatosensory evoked potentials (SSEPs) are not required in cases such as these. Certain types of IOMN can be performed under GA, as transmissions of sensory impulses are sent to the brain to identify neural irritation or injury and define the nature of the injury, which will allow the surgeon to complete the procedure without risking further injury.
Despite broad patient acceptance of SA for lower extremity procedures, and abundant evidence to support superior outcomes after orthopedic surgery, SA has never gained wide acceptance in lumbar spine surgery. Arguments against SA for lumbar decompression surgeries include the potential for airway complications in sedated prone positioned patients, the possibility for neural injury if an awake patient moves during decompressive procedures, the potential for intraoperative conversion to GA due to insufficient duration or failed SA, and confounding of the early postoperative neurologic examination.
The Erector Spinae Plane Block (ESP) is a novel fascial plane block, originally described as an effective treatment for thoracic neuritis. Since its first description, the ESP block has been applied to a broad range of surgical procedures, with benefits for opioid-sparing analgesia, a good safety profile, and few complications. The ESP block is considered to be relatively easy to perform when compared to other thoracic or neuraxial blocks, such as epidural and paravertebral blocks. The clinical findings of early studies have been supported by anatomical studies in cadavers demonstrating the appropriate spread of local anesthetic to the dorsal and ventral rami of the nerve roots of the thoracic spine.
The value of ESP block for spine surgery has likewise been suggested in case reports case series, and retrospective cohort studies. Each concludes significant opioid-sparing capacity and improved NRS pain scores in patients who receive ESP blocks for a variety of spine surgery procedures.
More recently, results from 2 RCTs describing outcomes after ESP block for lumbar decompression have been reported. In the first, 60 patients were randomized to receive bilateral ESPB or no intervention. NRS scores and tramadol consumption were significantly lower in the first 24 hours after surgery, and the time to requesting opioid analgesia was significantly longer in patients were received ESPB. In the second RCT, postoperative morphine consumption was lower in patients who received ESPB compared to patients who did not receive ESPB. NRS scores were lower up to 6 hours after surgery in the ESPB group, and patient satisfaction scores were higher
HSS anesthesiologists have been offering ESP blocks for spine surgery via posterior approach since 2017. A recent retrospective analysis of over 800 patients at HSS supports ESP blocks as analgesic and opioid-sparing in our spine surgery population.
As the above literature review suggests, there is unmet clinical and research need to explore the optimal anesthetic-analgesic regimen in patients undergoing minimally invasive lumbar decompression. This study has the potential to address the risk, benefits advantages and disadvantages of SOC GA for patients undergoing spine surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SA + ESP Block
Spinal Anesthesia: Patients will be provided with iv sedation, if desired, to facilitate placement of spinal anesthetic. Midazolam (2-5mg, iv), ketamine (up to 20 mg, lv) and/or propofol (0.1-0.2 mg/kg) will be permitted.
SA + ESP
The choice of local anesthetic for spinal anesthesia will be confirmed after consultation with the attending surgeon to determine duration of surgery. For expected surgical times less than 90 minutes, up to 4 mL 1.5% mepivacaine (60 mg) will be used. Where the anticipated surgical duration is longer than 90 minutes, 2 mL 0.5% bupivacaine (10 mg) may be substituted. After patient (prone) positioning, maintenance of sedation will be achieved with a target RASS score of 0 to -1.
Propofol (25-50 μg.kg.min-1) and ketamine (up to 50 mg total dose) infusions will be titrated to effect. Intermittent boluses of propofol (10-20mg) may be used to achieve the desired sedation, as needed.
Patients will be offered to option of awake surgery, where no sedation will be provided, if preferred. Patients will be informed that at any time before or during the procedure, they may change their mind, and receive sedation.
GA + ESP Block
General anesthesia: induction of general anesthesia to facilitate endotracheal intubation: fentanyl (up to 2μg.kg.min-1), propofol (1-2 mg.kg-1), vecuronium (1-2 mg.kg-1).
General anesthetic
Maintenance of general anesthesia: propofol infusion (50-150 μg.kg.min-1); ketamine infusion (up to 50 mg total); and inhaled anesthetic agent (isoflurane or sevoflurane) up to 0.5 MAC. N20 is not permitted.
Emergence from general anesthesia: N20 may be used during closure of the surgical incision to facilitate rapid emergence.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
General anesthetic
Maintenance of general anesthesia: propofol infusion (50-150 μg.kg.min-1); ketamine infusion (up to 50 mg total); and inhaled anesthetic agent (isoflurane or sevoflurane) up to 0.5 MAC. N20 is not permitted.
Emergence from general anesthesia: N20 may be used during closure of the surgical incision to facilitate rapid emergence.
SA + ESP
The choice of local anesthetic for spinal anesthesia will be confirmed after consultation with the attending surgeon to determine duration of surgery. For expected surgical times less than 90 minutes, up to 4 mL 1.5% mepivacaine (60 mg) will be used. Where the anticipated surgical duration is longer than 90 minutes, 2 mL 0.5% bupivacaine (10 mg) may be substituted. After patient (prone) positioning, maintenance of sedation will be achieved with a target RASS score of 0 to -1.
Propofol (25-50 μg.kg.min-1) and ketamine (up to 50 mg total dose) infusions will be titrated to effect. Intermittent boluses of propofol (10-20mg) may be used to achieve the desired sedation, as needed.
Patients will be offered to option of awake surgery, where no sedation will be provided, if preferred. Patients will be informed that at any time before or during the procedure, they may change their mind, and receive sedation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with one or two-level microdiscectomy, laminotomy, or foraminotomy - prior spine surgery is allowed only if surgery was preformed at other levels.
* Able to follow study protocol
* Able to provide informed consent
Exclusion Criteria
* Allergies of contraindication to any study anesthetic or analgesic medications.
* Morbid obesity, defined as BMI \> 35 kg/m2.
* Involved in the study of another investigational product that may affect the outcome.
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital for Special Surgery, New York
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital for Special Surgery
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tetzlaff JE, O'Hara J, Bell G, Grimm K, Yoon HJ. Influence of baricity on the outcome of spinal anesthesia with bupivacaine for lumbar spine surgery. Reg Anesth. 1995 Nov-Dec;20(6):533-7.
Koekemoer AM, Henkel C, Greenhill LJ, Dey A, van Breugel W, Codella C, Antonucci R. A water-vapour giga-maser in the active galaxy TXFS2226-184. Nature. 1995 Dec 14;378(6558):697-9. doi: 10.1038/378697a0.
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.
McLain RF, Kalfas I, Bell GR, Tetzlaff JE, Yoon HJ, Rana M. Comparison of spinal and general anesthesia in lumbar laminectomy surgery: a case-controlled analysis of 400 patients. J Neurosurg Spine. 2005 Jan;2(1):17-22. doi: 10.3171/spi.2005.2.1.0017.
Kilic ET, Naderi S. Effects of Anesthesia Protocol on Perioperative Outcomes and Costs of Lumbar Microdiscectomies. Turk Neurosurg. 2019;29(6):843-850. doi: 10.5137/1019-5149.JTN.25737-18.4.
Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.
Marks R. Keeping patient awake during spine surgery is cutting recovery time in half. https://www.ucsf.edu/news/2019/03/413446/spine-surgery-while-patients-are-awake-speeds-healing Accessed 1/24/2020
Harbers C. Duke spine surgeon offers awake surgery to patients. https://medschool.duke.edu/about-us/news-and-communications/som-magnify/duke-spine-surgeon-offers-awake-surgery-patients Accessed 1/24/2020
Kara I, Celik JB, Bahar OC. Comparison of spinal and general anesthesia in lumbar disc surgery. Journal of Neurological Sciences (Turkish) 28:487-496, 2011 9.
McLain RF, Tetzlaff JE, Bell GR, Uwe-Lewandrowski K, Yoon HJ, Rana M. Microdiscectomy: spinal anesthesia offers optimal results in general patient population. J Surg Orthop Adv. 2007 Spring;16(1):5-11.
Meng T, Zhong Z, Meng L. Impact of spinal anaesthesia vs. general anaesthesia on peri-operative outcome in lumbar spine surgery: a systematic review and meta-analysis of randomised, controlled trials. Anaesthesia. 2017 Mar;72(3):391-401. doi: 10.1111/anae.13702. Epub 2016 Oct 22.
Dagistan Y, Okmen K, Dagistan E, Guler A, Ozkan N. Lumbar Microdiscectomy Under Spinal and General Anesthesia: A Comparative Study. Turk Neurosurg. 2015;25(5):685-9. doi: 10.5137/1019-5149.JTN.10300-14.1.
Demirel CB, Kalayci M, Ozkocak I, Altunkaya H, Ozer Y, Acikgoz B. A prospective randomized study comparing perioperative outcome variables after epidural or general anesthesia for lumbar disc surgery. J Neurosurg Anesthesiol. 2003 Jul;15(3):185-92. doi: 10.1097/00008506-200307000-00005.
Dhall S, Gonzalez A, Jallo G, et al.
Krause KL, Cheaney Ii B, Obayashi JT, Kawamoto A, Than KD. Intraoperative neuromonitoring for one-level lumbar discectomies is low yield and cost-ineffective. J Clin Neurosci. 2020 Jan;71:97-100. doi: 10.1016/j.jocn.2019.08.116. Epub 2019 Sep 5.
Pajewski TN, Arlet V, Phillips LH. Current approach on spinal cord monitoring: the point of view of the neurologist, the anesthesiologist and the spine surgeon. Eur Spine J. 2007 Nov;16 Suppl 2(Suppl 2):S115-29. doi: 10.1007/s00586-007-0419-6. Epub 2007 Jul 10.
Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Hargett MJ, Lee BH, Wendel P, Brouillette M, Go G, Kim SJ, Baaklini L, Wetmore D, Hong G, Goto R, Jivanelli B, Argyra E, Barrington MJ, Borgeat A, De Andres J, Elkassabany NM, Gautier PE, Gerner P, Gonzalez Della Valle A, Goytizolo E, Kessler P, Kopp SL, Lavand'Homme P, MacLean CH, Mantilla CB, MacIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Pichler L, Poeran J, Poultsides LA, Sites BD, Stundner O, Sun EC, Viscusi ER, Votta-Velis EG, Wu CL, Ya Deau JT, Sharrock NE. Anaesthetic care of patients undergoing primary hip and knee arthroplasty: consensus recommendations from the International Consensus on Anaesthesia-Related Outcomes after Surgery group (ICAROS) based on a systematic review and meta-analysis. Br J Anaesth. 2019 Sep;123(3):269-287. doi: 10.1016/j.bja.2019.05.042. Epub 2019 Jul 24.
Attari MA, Mirhosseini SA, Honarmand A, Safavi MR. Spinal anesthesia versus general anesthesia for elective lumbar spine surgery: A randomized clinical trial. J Res Med Sci. 2011 Apr;16(4):524-9.
Greenbarg PE, Brown MD, Pallares VS, Tompkins JS, Mann NH. Epidural anesthesia for lumbar spine surgery. J Spinal Disord. 1988;1(2):139-43.
Hassi N, Badaoui R, Cagny-Bellet A, Sifeddine S, Ossart M. [Spinal anesthesia for disk herniation and lumbar laminectomy. Apropos of 77 cases]. Cah Anesthesiol. 1995;43(1):21-5. French.
Jellish WS, Thalji Z, Stevenson K, Shea J. A prospective randomized study comparing short- and intermediate-term perioperative outcome variables after spinal or general anesthesia for lumbar disk and laminectomy surgery. Anesth Analg. 1996 Sep;83(3):559-64. doi: 10.1097/00000539-199609000-00021.
Riegel B, Alibert F, Becq MC, Duckert I, Krivosic-Horber R. [Lumbar disk herniation with surgical option: general versus local anesthesia. Round table]. Agressologie. 1994;34 Spec No 1:33-7. French.
Tetzlaff JE, Baird BA, Yoon HJ. Spinal anesthesia with plain bupivicaine for lumbar spine surgery. Can J Anaesth. 1990 May;37(4 Pt 2):S61. No abstract available.
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Brandão J, Mamôru T: Sakae Erector Spine Plane Block in Different Surgeries. J Anes Perio Manag 4: 005
Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.
Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855.
Singh S, Chaudhary NK. Bilateral Ultasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery: A Case Series. J Neurosurg Anesthesiol. 2019 Jul;31(3):354. doi: 10.1097/ANA.0000000000000518. No abstract available.
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.
Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
Soffin et al, 2021, in prep, personal communication
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-2478
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.