Lumbar Disc HerniationPhase 3NCT05444751
GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries
A Phase 3 study testing General anesthetic and SA + ESP in people with Lumbar Disc Herniation and Lumbar Disc Disease, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Disc Disease, Lumbar Radiculopathy
- What is being tested?
- General anesthetic and SA + ESP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients from the ages 18- 80 years
- 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
Who cannot join
- Surgery with planned need for postoperative surgical drain.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Evaluating General Anesthesia With Erector Spinae Plane Block vs. Spinal Anesthesia With Erector Spinae Plane Block in Lumbar Decompression Surgeries
The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.
Read the detailed description
An early comparative analysis between GA and SA in spine surgery explored perioperative effects of the technique on cost and satisfaction among patients, anesthesiologists, and surgeons. Patients who underwent surgery under SA had better outcomes, including hemodynamic stability, shorter hospitalization time, and shorter time to return to work. Postoperatively, SA was associated with lower numeric pain rating scale (NPRS) scores and earlier time to mobilization and first oral intake. Moreover, SA had lower costs and higher reported satisfaction among patients, surgeons, and anesthesiologists.
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.
- Being tested
- General anesthetic, SA + ESP
- Keywords
- Degenerative Disc Disease, Lumbar Spine
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral disc disease, Radiculopathy, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anestheticDrug
Also called GA + ESP
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 + ESPDrug
Also called Erector Spinae Block
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.
| Study group | Role | What they receive |
|---|---|---|
| SA + ESP Block | Experimental | 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. Receives: Drug: SA + ESP |
| GA + ESP Block | Active comparator | 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). Receives: Drug: General anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR15 survey scores
The primary outcome is the difference in the quality of recovery-15 (QoR15) score between the groups at each timepoint (before surgery, after surgery, and at their first 2 week follow-up visit). For this survey, a high number represents something that occurs often, while a low number indicates something that rarely or never occurs. Depending on the category/question asked, this may be good or bad. The questions on the survey will be split and compared so that for one subset of questions a high number is good while the opposite is true for the other subset of questions. This will be done so the comparison between groups is more accurate and meaningful.
Measured: The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits
Secondary outcomes (5)
NRS Survey Pain Scores
Numeric rating scale (NRS) survey will be asked in holding (before surgery), in the PACU (after surgery), and at the patients first 2week follow-up visit. Most patients will be discharged a few hours after waking up, barring no complications, therefore may only be assessed the NRS survey immediately after surgery (same as QoR15). For this scale (0-10), a higher number indicates more pain in that specified body part, while a lower score indicates little or no pain in that body part.
Measured: The NRS will be assessed preoperatively (in holding area), postoperatively in PACU, and 2 weeks postoperatively at the patient's first follow-up
Opioid Consumption
Opioid consumption will be tracked intraoperatively and total from PACU arrival to 24 hours surgery
Measured: From surgery through 24 hours postoperatively
Anesthetic(s) Time
induction (from induction to anesthesia-ready), emergence (from surgery-end to out-of-OR for SA group; and from surgery-end to extubation for GA groups); duration of SA (from placement to resolution).
Measured: Intraoperatively
Surgical Duration
Time of surgery will be compared between groups from skin incision to skin closure
Measured: Intraoperatively
Complications
nausea, vomiting, urinary retention, escalation to a higher level of postoperative care, conversion from SA to GA, neurologic (extremity numbness, weakness, paresthesia).
Measured: Length of stay at the hospital (up to 3 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start22 Mar 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444751
- Sponsor's protocol ID
- 2020-2478
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 15658121Kilic 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.
PubMed 30984998Melvin 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.
PubMed 29704223Marks 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.
PubMed 17371640Meng 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.
PubMed 27770448Dagistan 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.
PubMed 26442531Demirel 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.
PubMed 12826965Dhall 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.
PubMed 31495654Pajewski 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.
PubMed 17619913Memtsoudis 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.
PubMed 31351590Attari 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.
PubMed 22091269
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating General Anesthesia With Erector Spinae Plane Block vs. Spinal Anesthesia With Erector Spinae Plane Block in Lumbar Decompression Surgeries
- ClinicalTrials.gov ID
- NCT05444751
- Acronym / sponsor ID
- 2020-2478
- Keywords
- Degenerative Disc Disease, Lumbar Spine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.
Detailed description
An early comparative analysis between GA and SA in spine surgery explored perioperative effects of the technique on cost and satisfaction among patients, anesthesiologists, and surgeons. Patients who underwent surgery under SA had better outcomes, including hemodynamic stability, shorter hospitalization time, and shorter time to return to work. Postoperatively, SA was associated with lower numeric pain rating scale (NPRS) scores and earlier time to mobilization and first oral intake. Moreover, SA had lower costs and higher reported satisfaction among patients, surgeons, and anesthesiologists.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SA + ESP Block | Experimental | Drug: SA + ESPSpinal 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. |
| GA + ESP Block | Active comparator | Drug: General anestheticGeneral 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients from the ages 18- 80 years
- 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
Key exclusion criteria (4 listed)
- Surgery with planned need for postoperative surgical drain.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anestheticAlso: GA + ESPMaintenance 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. | Drug | GA + ESP Block |
| SA + ESPAlso: Erector Spinae BlockThe 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. | Drug | SA + ESP Block |
Primary outcome
QoR15 survey scores
Time frame: The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits
The primary outcome is the difference in the quality of recovery-15 (QoR15) score between the groups at each timepoint (before surgery, after surgery, and at their first 2 week follow-up visit). For this survey, a high number represents something that occurs often, while a low number indicates something that rarely or never occurs. Depending on the category/question asked, this may be good or bad. The questions on the survey will be split and compared so that for one subset of questions a high number is good while the opposite is true for the other subset of questions. This will be done so the comparison between groups is more accurate and meaningful.
5 secondary outcomes
NRS Survey Pain Scores
Time frame: The NRS will be assessed preoperatively (in holding area), postoperatively in PACU, and 2 weeks postoperatively at the patient's first follow-up
Opioid Consumption
Time frame: From surgery through 24 hours postoperatively
Anesthetic(s) Time
Time frame: Intraoperatively
Surgical Duration
Time frame: Intraoperatively
Complications
Time frame: Length of stay at the hospital (up to 3 days postoperatively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 15658121McLain 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.
- Background: PubMed 30984998Kilic 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.
- Background: PubMed 29704223Melvin 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.
- BackgroundMarks 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
- BackgroundHarbers 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
- BackgroundKara 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.
- Background: PubMed 17371640McLain 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.
- Background: PubMed 27770448Meng 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.
- Background: PubMed 26442531Dagistan 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.
- Background: PubMed 12826965Demirel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing General anesthetic and SA + ESP in people with Lumbar Disc Herniation and Lumbar Disc Disease, run by Hospital for Special Surgery, New York at 1 site in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR15 survey scores (time frame: The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits). 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 NCT05444751, which also lists 32 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 28 Apr 2026.