Multimodal Analgesia Versus Routine Care Pain Management (MMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Frank M. Phillips, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01861743
First received: May 8, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.

Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).

A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.

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 compared to usual analgesic care.


Condition Intervention
Degenerative Disc Disease Lumbar
Spinal Stenosis
Lumbar Spondylolisthesis
Other: Multimodal Analgesia
Other: Patient controlled analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Numeric pain scale [ Time Frame: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years. ] [ Designated as safety issue: No ]
    (a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain 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.


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: Post operatively (avg: 1-3 days) ] [ Designated as safety issue: No ]
    At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no)


Other Outcome Measures:
  • Length of Stay [ Time Frame: Post operatively (avg: 1-3 days) ] [ Designated as safety issue: No ]
  • Discharge destination [ Time Frame: Post operatively (avg:1-3 days) ] [ Designated as safety issue: No ]
    Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)

  • Adverse events [ Time Frame: Post operatively (avg: 1-3 days) ] [ Designated as safety issue: No ]
  • Disease specific and General health outcome measures [ Time Frame: Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years) ] [ Designated as safety issue: No ]
    Short form 36 and the Oswestry Disabilty Index


Estimated Enrollment: 124
Study Start Date: April 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multimodal analgesia
multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols.
Other: Multimodal Analgesia
Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
Active Comparator: Patient Controlled analgesia
Pain management using patient controlled narcotic analgesia.
Other: Patient controlled analgesia
Subjects will be treated with patient controlled narcotic analgesia for pain management.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing single level MIS-TLIF
  • Patients able to provide informed consent

Exclusion Criteria:

  • Allergies or other contraindications to medicines in the protocol
  • Current liver disease with documented liver function test abnormality
  • Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
  • Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
  • Active alcohol dependence
  • Active illicit drug dependence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861743

Locations
United States, Illinois
Rush University Medical Center-Orthopedic Spine Recruiting
Chicago, Illinois, United States, 60612
Contact: Frank M Phillips, MD    312-243-4244    frank.phillips@rushortho.com   
Contact: Susan Dvojack, MS    3129426689    susan_dvojack@rush.edu   
Principal Investigator: Frank M Phillips, MD         
Sub-Investigator: Kern Singh, MD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Frank M Phillips, MD Rush University Medical Center
  More Information

Publications:
Responsible Party: Frank M. Phillips, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01861743     History of Changes
Other Study ID Numbers: 13020402
Study First Received: May 8, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Multi-modal Pain Management
Lumbar fusion
misTLIF

Additional relevant MeSH terms:
Spinal Stenosis
Spondylolisthesis
Intervertebral Disk Degeneration
Intervertebral Disk Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014