Phase 4 Peripheral Neuropathy Trial, Recruiting NCT05029726 Sponsor: John O'Toole Condition: Peripheral Neuropathy
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Phase 4 Peripheral Neuropathy Trial, Recruiting

NCT05029726
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 80 years old
  • People who are scheduled to have one of these specific back surgeries: (1) a minimally invasive spine decompression procedure at two or more spinal levels (such as a discectomy, foraminotomy, or laminectomy); (2) a minimally invasive spinal fusion procedure called TLIF at one to three spinal levels, with or without additional decompression, for no more than three total spinal levels treated; or (3) a spinal fusion procedure through the front or side of the body (ALIF or LLIF) at one to three levels, combined with a minimally invasive fixation procedure from the back at the same levels
  • People who are willing and able to give their informed consent to participate

Who may not be able to join:

  • People who regularly use opioid pain medications at a daily dose equivalent to more than 30mg of morphine at the time of surgery (confirm with trial site)
  • People who have an implanted pain-relief device, such as an intrathecal opioid pump, spinal cord stimulator, or dorsal root ganglion stimulator
  • People with a known allergy to bupivacaine, clonidine, or similar local anaesthetic medications
  • People whose reason for surgery is something other than degenerative spine disease, such as a tumour, infection, or injury
  • People with moderate-to-severe chronic kidney disease (stage 3 or higher) or liver failure
  • People who are currently pregnant
  • People with a medical condition or mental health condition that would make it difficult to accurately assess pain levels around the time of surgery (confirm with trial site)
  • People who are currently involved in an active Workers' Compensation legal claim

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: John O'Toole, MD, Rush University Medical Center

Phone: (888) 352-7874

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
John O'Toole
Registry
ClinicalTrials.gov
Start date
1 February 2022
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Inpatient opioid consumption

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov