Recruiting

Regional Anesthesia

Sponsor:

John O'Toole

Code:

NCT05029726

Conditions

Lumbar Spinal Stenosis

Lumbar Disc Herniation

Lumbar Spondylolisthesis

Lumbar Spondylosis

Lumbar Radiculopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine

normal saline

Study Details

Brief 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. 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.

Conditions

Lumbar Spinal Stenosis

Lumbar Disc Herniation

Lumbar Spondylolisthesis

Lumbar Spondylosis

Lumbar Radiculopathy

Study ID

NCT05029726

Start date

Feb 1, 2022

Status verified date

Feb, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Investigational

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.

placebo comparator: Control

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.

Interventions

Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine

Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB

normal saline

normal saline in 30cc syringes administered using ESPB technique

Primary outcome measure

  • Inpatient opioid consumption [ Time Frame: Every 1 day during inpatient admission up to 30 days ]

Central Contacts and Locations

Central contacts

Bart Jacher

(888) 352-7874bartosz_jacher@rush.edu

Morgan Mulcahy

(888) 352-7874morgan_l_mulcahy@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Bart Jacher

888-352-7874bartosz_jacher@rush.edu

Morgan Mulcahy

(888) 352-7874morgan_l_mulcahy@rush.edu

Principal Investigator:

John O'Toole, MD

More Information

Sponsor

John O'Toole

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • erector spinae plane block
  • minimally invasive spine surgery
  • regional anesthesia
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by John O'Toole on 2026-02-17.