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

NCT02202369 | Suspended Phase 4 DMC

• 1 other identifier: 9080
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multimodal Analgesia; Pain Management

Outcome Measures

Primary Outcomes (1)

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

  While in the hospital, patient's pain is assessed by a nurse-driven standard of care protocol. Assessments are typically every four to six hours or within 60 minutes after receiving an intravenous or oral analgesic medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.

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

Secondary Outcomes (6)

• Patient satisfaction

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

• Narcotic consumption

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

• Length of stay

  Hospital discharge (an expected average of 2 days after surgery)

• Discharge destination

  Hospital discharge (an expected average of 2 days after surgery)

• Oswestry Disability Index (ODI)

  pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative

Study Arms (2)

Multimodal Analgesia (MMA) Treatment

EXPERIMENTAL

Other: Multimodal Analgesia Treatment

Standard of Care Pain Managment Protocol

ACTIVE COMPARATOR

Other: Standard of Care Pain Management Protocol

Interventions

Multimodal Analgesia Treatment OTHER

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.

Multimodal Analgesia (MMA) Treatment

Standard of Care Pain Management Protocol OTHER

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

Standard of Care Pain Managment Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients with active alcohol dependence
• Patients with active illicit drug dependence
• Patients \< 18 years of age and \>70 years of age
• Patients allergic to any medication given in either arm (list medications)
• Patients who have a seizure disorder

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• Charlotte Orthopedic Hospital: collaborator

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alden Milam, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 29, 2014
• Study Start: June 25, 2015
• Primary Completion: February 3, 2020
• Study Completion (Estimated): December 31, 2050
• Last Updated: April 28, 2025

Record last verified: 2025-04

Locations

US (1)