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Multimodal Analgesia Versus Routine Care Pain Management (MMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01861743
Recruitment Status : Terminated (data was not collected accurately)
First Posted : May 24, 2013
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
Frank M. Phillips, MD, Rush University Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Degenerative Disc Disease Lumbar Spinal Stenosis Lumbar Spondylolisthesis Other: Multimodal Analgesia Other: Patient controlled analgesia Not Applicable

Detailed Description:

We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:

  1. decreased post-operative pain compared to patients receiving usual care for pain management.
  2. shorter hospital LOS compared to patients receiving usual care pain management.
  3. fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
  4. improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
  5. better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
Study Start Date : April 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Other Outcome Measures:
  1. Length of Stay [ Time Frame: Post operatively (avg: 1-3 days) ]
  2. Discharge destination [ Time Frame: Post operatively (avg:1-3 days) ]
    Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)

  3. Adverse events [ Time Frame: Post operatively (avg: 1-3 days) ]
  4. 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) ]
    Short form 36 and the Oswestry Disabilty Index

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01861743

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United States, Illinois
Rush University Medical Center-Orthopedic Spine
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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Principal Investigator: Frank M Phillips, MD Rush University Medical Center

Publications of Results:
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Responsible Party: Frank M. Phillips, MD, MD, Rush University Medical Center Identifier: NCT01861743     History of Changes
Other Study ID Numbers: 13020402
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Frank M. Phillips, MD, Rush University Medical Center:
Multi-modal Pain Management
Lumbar fusion
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases