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Can a simple painkiller help curb opioid use after back surgery?

NCT ID NCT03020875

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving acetaminophen (Tylenol) through an IV works better than pills for pain after lumbar spine surgery. 166 adults having a specific type of back fusion surgery were randomly assigned to receive either IV or oral acetaminophen. The goal was to see if the IV version could reduce pain and cut down on the need for stronger opioid painkillers, which carry risks of addiction and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acetaminophen (paracetamol)
What this could lead to
If IV acetaminophen proves better, it could offer a way to manage pain after spine surgery with fewer opioids and less nausea.
What could go wrong
This is a small, single-center trial comparing two forms of a common drug, so any benefit may be modest and not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jan 2017

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis * Skeletally mature adults between the ages of 18-85 years at the time of surgery * The greater of the patients right and left VAS leg pain, or back pain, score is \> 40 mm on a 100 mm scale * Has attempted conservative therapy * Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures * Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study Exclusion Criteria: * Any evidence of a prior/current fracture, compromised vertebra, current or past trauma, or tumor at affected level or the spinous processes at the adjacent levels * Revision of prior fusion attempt at the level being operated on * Cauda Equina Syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence) * Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis * Significant peripheral vascular disease (diminished dornails pedis or tibial pulses) * Morbid obesity, defined as BMI \> 40 kg/m2; or underweight, defined as BMI \< 18.5 kg/m2 * Active systematic or local infection * Active Viral Hepatitis (receiving medical treatment within 1 year); or any other acute hepatitis within the past 6 months * Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia * Insulin dependent diabetes mellitus or any other medical conditions that would represent a significant increase in surgical risk or interfere with normal healing * Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose for \>1 month within last 12 months * History of Paget's disease, osteomalacia, or osteoporosis with a DEXA t-score less than or equal to -2.5 * Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy \>5 years * Any current history of substance abuse (e.g., recreational drugs, narcotics, or alcohol) * History of psychosocial disorders that could prevent accurate completion of self-reporting assessment scales * Previous known allergy to acetaminophen * Women who are pregnant or lactating * Patients involved in active litigation relating to his/her spinal condition * Patients taking \>30mg/day of oral morphine sulfate, or the equivalent of this daily for more than 3 months * Patient is unable to ingest orally administered medication * Patient receiving autologous Iliac Crest bone graft (ICBG) * Known intolerance of or true allergy to hydromorphone or oxycodone. * History of moderate to severe Cirrhosis, defined as Child Pugh score of class B, C, or D * History of Hemochromatosis or Porphyria * Patient taking Isoniazid or barbiturates

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital for Special Surgery

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.