TerminatedPhase 4

Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

Stopped: Low enrollment and subject followup rates

United States50 participantsStarted 2015-06-25

Plain-language summary

The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to usual analgsic care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects undergoing a single level lumbar decompression and fusion
. \> 18 years of age and \< 70 years of age
. The subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study

Exclusion criteria

. Patients with liver disease (documented liver function test abnormality)
. Patients with renal disease (documented glomerular filtration rate \< 60mL/min/1.73m2)
. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient reported pain level using a verbal numeric pain scale (NPS)

Timeframe: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)

Trial details

NCT IDNCT02202369

SponsorOrthoCarolina Research Institute, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-03

View on ClinicalTrials.gov More Single Level Lumbar Decompression and Fusion Spine Surgery trials