Treatment for Multimodal Analgesic Approach

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Hospital for Special Surgery, New York, NY
Multimodal Analgesic Approach
Eligibility
18+
All Sexes
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Study Summary

IV vs Oral Acetaminophen in Spine Fusion Perioperative Care

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Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Multimodal Analgesic Approach

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Multimodal Analgesic Approach. Measurement will happen over the course of Postoperative.

6 months Postoperative
Long Term Opioid Usage
Month 6
Visual Analog Scale (VAS) for back and legs
Immediate postoperative
Length of Stay (LOS)
Time to Ambulation
Postoperative
Opioid Equivalent Dosing during Hospital Stay
Month 6
Oswestry Disability Index Version 2.1 (ODI)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Multimodal Analgesic Approach

Trial Design

2 Treatment Groups

PO Acetaminophen
1 of 2
Intravenous Acetaminophen
1 of 2
Active Control

This trial requires 166 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

PO Acetaminophen
Drug
Preop: Eligible patients will receive oral acetaminophen within 3 hours of OR start time. Postop: Eligible patients will be administered oral acetaminophen following 1 and 2 level LLIFs supplemented with instrumented posterior fusion to evaluate pain management outcomes. Dosing for the group will be the following: • Oral Acetaminophen 1,000 mg every 6 hours for 48 hours postoperative. Medication will be given at least 6 hours following initial preoperative dose of oral acetaminophen. Postop supplemental pain medications: All patients will receive a standardized hydromorphone IV-PCA order set for 24 hours postoperatively. The use of tramadol and tapentadol will specifically be discouraged due to challenges in determining morphine-equivalent dosing with these specific agents. Similarly, acetaminophen containing combination products (e.g. oxycodone/acetaminophen or hydrocodone/acetaminophen) will not be allowed due to overlap with the primary study medications.
Intravenous Acetaminophen
Drug
Preop: Eligible patients will receive IV acetaminophen within 3 hours of OR start time. Postop: Eligible patients will be administered IV acetaminophen following 1 and 2 level LLIFs supplemented with instrumented posterior fusion to evaluate pain management outcomes. Dosing for the group will be the following: • IV Acetaminophen 1,000 mg [100 ml] every 6 hours for 48 hours postoperative. Medication will be given at least 6 hours following initial preoperative dose of IV acetaminophen. Postop supplemental pain medications: All patients will receive a standardized hydromorphone IV-PCA order set for 24 hours postoperatively. The use of tramadol and tapentadol will specifically be discouraged due to challenges in determining morphine-equivalent dosing with these specific agents. Similarly, acetaminophen containing combination products (e.g. oxycodone/acetaminophen or hydrocodone/acetaminophen) will not be allowed due to overlap with the primary study medications.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: preoperative, 6 weeks and 6 months postoperative
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly preoperative, 6 weeks and 6 months postoperative for reporting.

Closest Location

Hospital for Special Surgery - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

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