Lumbar Spinal StenosisPhase 4NCT05029726
Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
A Phase 4 study testing Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine and normal saline in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by John O'Toole at 1 site in United States.
Trial summary
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis
- What is being tested?
- Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Apr 2027
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels
- Willing and able to give consent
Who cannot join
- Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
- Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
- Known allergy to bupivacaine, clonidine or similar local anesthetics
- Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
- Chronic kidney disease (stage 3 or greater), or hepatic failure
- Active pregnancy
- Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period
- Active Worker's Compensation litigation
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, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Bart Jacher, 888-352-7874, bartosz_jacher@rush.edu
Morgan Mulcahy, (888) 352-7874, morgan_l_mulcahy@rush.edu
About this study
Official title: Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
Read the detailed description
Opioid abuse and misuse remain a public health crisis in the United States, notably in patients with chronic pain from degenerative spine disease. Perioperative pain management for patients undergoing spinal surgery remains largely reliant on opioid medications, with several known adverse effects including, but not limited to delirium, postoperative urinary retention (POUR), constipation and nausea. These side effects contribute to increased hospital length of stay (LOS) with increased incidence of overall in-hospital complications, perioperative costs, and increased rates of opioid habituation and addiction.
Dependence on prescription opioids has been associated with wide-ranging social and economic consequences including increased opioid overdose resulting in death, growing opioid-related incarcerations, and spiraling opioid-related healthcare cost from treatment of addiction, opioid-related mental health issues, and debilitating chronic pain. Long-term requirements for opioid medications may be associated with the use of higher doses of opioids in the perioperative period for patients undergoing invasive surgery for spinal degenerative conditions. Studies have demonstrated that patients who consume fewer opioids for 30 days after surgery are less likely to progress to become chronic opioid users. Regional analgesic techniques have shown promise in decreasing post-operative pain and opioid requirements in thoracic and abdominal surgery but difficulties with post-operative neurological assessments have limited their use in spinal surgery. Inter-fascial plane blocks, however, have emerged as a safe and potentially useful regional analgesic technique to mitigate the pain-inducing effects of posterior spine surgery.
Erector Spinae Plane Blocks (ESPBs), specifically, involve ultra-sound guided injection of local anesthetic (LA) posteriorly beneath the erector spinae muscles resulting in longitudinal and ventrolateral spread of the anesthetic into the paravertebral space where the ventral and dorsal rami of the spinal nerves are located thereby inducing a multi-level analgesic effect. Depending upon the LA used, this effect may last for 4 to 36 hours.
The proposed study will examine the efficacy of preoperative ESPBs in reducing post-operative opioid utilization and its associated complications specifically after minimally invasive (MIS) lumbar spine surgery including both decompressive and instrumented fusion procedures. The guiding principle of MIS spine surgery is reduction of iatrogenic injury by utilizing muscle dilating approaches and tubular retractors rather than conventional open, subperiosteal muscle stripping techniques. The latter typically results in muscle denervation and devascularization as well as postoperative muscle atrophy and dead space creation that increase postoperative pain, muscle dysfunction, prolonged recovery times and complications. Since MIS spinal surgical procedures preserve normal paraspinal musculature compared to open surgery, the magnitude of effect of ESPBs may actually be more pronounced in this population.
The investigators hypothesize that by conducting this investigation within the rigor of a double-blinded, randomized placebo-controlled clinical trial, the results will definitively demonstrate that the addition of regional analgesia in the form of ESPB during MIS lumbar spine surgery will 1) reduce post-operative opioid consumption and 2) reduce opioid-related complications and hospital LOS but 3) have no adverse effects on postoperative pain control.
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spondylosis, Lumbar Radiculopathy, Lumbar Spine Instability
- Being tested
- Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine, normal saline
- Keywords
- erector spinae plane block, minimally invasive spine surgery, regional anesthesia, randomized controlled trial
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Spondylolisthesis, Spondylosis, Radiculopathy, Synovial Cyst, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidineDrug
Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
normal salineDrug
normal saline in 30cc syringes administered using ESPB technique
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance. Receives: Drug: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine |
| Control | Placebo comparator | Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient opioid consumption
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
Measured: Every 1 day during inpatient admission up to 30 days
Secondary outcomes (11)
Post-discharge opioid consumption
Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients
Measured: 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
Postoperative opioid prescriptions filled
- Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website
Measured: From hospital discharge to 90 days postoperatively
Length of hospital stay
Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria
Measured: From time of surgery to time discharge criteria met in hours, up to 2160 hours
Postoperative Urinary Retention (POUR)
Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement
Measured: Immediately post-surgery to discharge, up to 90 days
Post-operative delirium
Incidence of post-operative delirium as measured by the need for placement of physical restraints
Measured: Immediately post-surgery to discharge
Post-operative delirium
Incidence of post-operative delirium as measured by the administration of new anti-psychotic medications
Measured: Immediately post-surgery to discharge, up to 90 days
Postoperative pain scores
Mean daily VAS (visual analog scale) pain scores recorded in the electronic medical record (EMR)
Measured: Every 1 day during inpatient admission up to 30 days
Patient-reported pain and functional outcomes
Change in Visual Analog Scale (VAS) for pain in the back and leg (0-10 with 10 being worst)
Measured: From baseline preoperative values to 6 week post-operative values
Patient-reported pain and functional outcomes
Change in Oswestry Disability Index (ODI; 0 to 100 with 100 being worst)
Measured: From baseline preoperative values to 6 week post-operative values
Patient-reported pain and functional outcomes
Change in Short Form 12/6D (SF-12/6D; 0 to 100 with 0 being worst)
Measured: From baseline preoperative values to 6 week post-operative values
Peri-operative complications
Prospectively documented medical and surgical complications/adverse events (AEs) including rates of readmission or reoperation for AEs
Measured: Time of surgery to 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Feb 2022
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will undergo surgery using an enhanced recovery after surgery (ERAS) multi-modal anesthesia protocol that is currently in standard use for MIS lumbar spine surgical procedures. Patients will be randomized in a 1:1 ratio to investigational and control arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John O'Toole
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John O'Toole, Rush University Medical Center
- Investigators
- John O'Toole, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029726
- Sponsor's protocol ID
- ORA20050502
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30180150Chin KJ, Dinsmore MJ, Lewis S, Chan V. Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients. Eur Spine J. 2020 Dec;29(Suppl 2):138-144. doi: 10.1007/s00586-019-06133-8. Epub 2019 Sep 3.
PubMed 31482311Forero 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.
PubMed 27501016Melvin 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 29704223Singh 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.
PubMed 31033625Ueshima 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.
PubMed 30424594van den Broek RJC, van de Geer R, Schepel NC, Liu WY, Bouwman RA, Versyck B. Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery. Sci Rep. 2021 Apr 7;11(1):7631. doi: 10.1038/s41598-021-87374-w.
PubMed 33828209Armaghani SJ, Lee DS, Bible JE, Archer KR, Shau DN, Kay H, Zhang C, McGirt MJ, Devin CJ. Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery. Spine (Phila Pa 1976). 2014 Dec 1;39(25):E1524-30. doi: 10.1097/BRS.0000000000000622.
PubMed 25417827Kalakoti P, Hendrickson NR, Bedard NA, Pugely AJ. Opioid Utilization Following Lumbar Arthrodesis: Trends and Factors Associated With Long-term Use. Spine (Phila Pa 1976). 2018 Sep 1;43(17):1208-1216. doi: 10.1097/BRS.0000000000002734.
PubMed 30045343
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT05029726
- Acronym / sponsor ID
- ORA20050502
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spondylosis, Lumbar Radiculopathy, Lumbar Spine Instability
- Keywords
- erector spinae plane block, minimally invasive spine surgery, regional anesthesia, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- John O'TooleUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Aug 2021 (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.
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
Detailed description
Opioid abuse and misuse remain a public health crisis in the United States, notably in patients with chronic pain from degenerative spine disease. Perioperative pain management for patients undergoing spinal surgery remains largely reliant on opioid medications, with several known adverse effects including, but not limited to delirium, postoperative urinary retention (POUR), constipation and nausea. These side effects contribute to increased hospital length of stay (LOS) with increased incidence of overall in-hospital complications, perioperative costs, and increased rates of opioid habituation and addiction.
Dependence on prescription opioids has been associated with wide-ranging social and economic consequences including increased opioid overdose resulting in death, growing opioid-related incarcerations, and spiraling opioid-related healthcare cost from treatment of addiction, opioid-related mental health issues, and debilitating chronic pain. Long-term requirements for opioid medications may be associated with the use of higher doses of opioids in the perioperative period for patients undergoing invasive surgery for spinal degenerative conditions. Studies have demonstrated that patients who consume fewer opioids for 30 days after surgery are less likely to progress to become chronic opioid users. Regional analgesic techniques have shown promise in decreasing post-operative pain and opioid requirements in thoracic and abdominal surgery but difficulties with post-operative neurological assessments have limited their use in spinal surgery. Inter-fascial plane blocks, however, have emerged as a safe and potentially useful regional analgesic technique to mitigate the pain-inducing effects of posterior spine surgery.
Erector Spinae Plane Blocks (ESPBs), specifically, involve ultra-sound guided injection of local anesthetic (LA) posteriorly beneath the erector spinae muscles resulting in longitudinal and ventrolateral spread of the anesthetic into the paravertebral space where the ventral and dorsal rami of the spinal nerves are located thereby inducing a multi-level analgesic effect. Depending upon the LA used, this effect may last for 4 to 36 hours.
The proposed study will examine the efficacy of preoperative ESPBs in reducing post-operative opioid utilization and its associated complications specifically after minimally invasive (MIS) lumbar spine surgery including both decompressive and instrumented fusion procedures. The guiding principle of MIS spine surgery is reduction of iatrogenic injury by utilizing muscle dilating approaches and tubular retractors rather than conventional open, subperiosteal muscle stripping techniques. The latter typically results in muscle denervation and devascularization as well as postoperative muscle atrophy and dead space creation that increase postoperative pain, muscle dysfunction, prolonged recovery times and complications. Since MIS spinal surgical procedures preserve normal paraspinal musculature compared to open surgery, the magnitude of effect of ESPBs may actually be more pronounced in this population.
The investigators hypothesize that by conducting this investigation within the rigor of a double-blinded, randomized placebo-controlled clinical trial, the results will definitively demonstrate that the addition of regional analgesia in the form of ESPB during MIS lumbar spine surgery will 1) reduce post-operative opioid consumption and 2) reduce opioid-related complications and hospital LOS but 3) have no adverse effects on postoperative pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients will undergo surgery using an enhanced recovery after surgery (ERAS) multi-modal anesthesia protocol that is currently in standard use for MIS lumbar spine surgical procedures. Patients will be randomized in a 1:1 ratio to investigational and control arms.
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Drug: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidinePatients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance. |
| Control | Placebo comparator | Drug: normal salinePatients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80
- Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels
- Willing and able to give consent
Key exclusion criteria (8 listed)
- Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
- Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
- Known allergy to bupivacaine, clonidine or similar local anesthetics
- Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
- Chronic kidney disease (stage 3 or greater), or hepatic failure
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 |
|---|---|---|
| Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidineBupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB | Drug | Investigational |
| normal salinenormal saline in 30cc syringes administered using ESPB technique | Drug | Control |
Primary outcome
Inpatient opioid consumption
Time frame: Every 1 day during inpatient admission up to 30 days
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
11 secondary outcomes
Post-discharge opioid consumption
Time frame: 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
Postoperative opioid prescriptions filled
Time frame: From hospital discharge to 90 days postoperatively
Length of hospital stay
Time frame: From time of surgery to time discharge criteria met in hours, up to 2160 hours
Postoperative Urinary Retention (POUR)
Time frame: Immediately post-surgery to discharge, up to 90 days
Post-operative delirium
Time frame: Immediately post-surgery to discharge
Post-operative delirium
Time frame: Immediately post-surgery to discharge, up to 90 days
Postoperative pain scores
Time frame: Every 1 day during inpatient admission up to 30 days
Patient-reported pain and functional outcomes
Time frame: From baseline preoperative values to 6 week post-operative values
Patient-reported pain and functional outcomes
Time frame: From baseline preoperative values to 6 week post-operative values
Patient-reported pain and functional outcomes
Time frame: From baseline preoperative values to 6 week post-operative values
Peri-operative complications
Time frame: Time of surgery to 6 weeks postoperative
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 17 Feb 2026.
- Background: PubMed 30180150Chin 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.
- Background: PubMed 31482311Chin KJ, Dinsmore MJ, Lewis S, Chan V. Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients. Eur Spine J. 2020 Dec;29(Suppl 2):138-144. doi: 10.1007/s00586-019-06133-8. Epub 2019 Sep 3.
- Background: PubMed 27501016Forero 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.
- 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.
- Background: PubMed 31033625Singh 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.
- Background: PubMed 30424594Ueshima 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.
- Background: PubMed 33828209van den Broek RJC, van de Geer R, Schepel NC, Liu WY, Bouwman RA, Versyck B. Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery. Sci Rep. 2021 Apr 7;11(1):7631. doi: 10.1038/s41598-021-87374-w.
- Background: PubMed 25417827Armaghani SJ, Lee DS, Bible JE, Archer KR, Shau DN, Kay H, Zhang C, McGirt MJ, Devin CJ. Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery. Spine (Phila Pa 1976). 2014 Dec 1;39(25):E1524-30. doi: 10.1097/BRS.0000000000000622.
- Background: PubMed 30045343Kalakoti P, Hendrickson NR, Bedard NA, Pugely AJ. Opioid Utilization Following Lumbar Arthrodesis: Trends and Factors Associated With Long-term Use. Spine (Phila Pa 1976). 2018 Sep 1;43(17):1208-1216. doi: 10.1097/BRS.0000000000002734.
- Individual participant dataSharing planned: No
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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.
John O'Toole, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine and normal saline in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by John O'Toole 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Feb 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Bart Jacher ((888) 352-7874, bartosz_jacher@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient opioid consumption (time frame: Every 1 day during inpatient admission up to 30 days). 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 NCT05029726, which also lists 9 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 17 Feb 2026.