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

NCT02202369 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Single Level Lumbar Decompression and Fusion Spine Surgery

Interventions

OTHER

Multimodal Analgesia Treatment

Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.

OTHER

Standard of Care Pain Management Protocol

Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)

Sponsors & Collaborators

  • Charlotte Orthopedic Hospital

    collaborator OTHER

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Alden Milam, MD · OrthoCarolina Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-25
Primary Completion
2020-02-03
Completion
2020-09-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202369 on ClinicalTrials.gov