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

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ClinicalTrials.gov Identifier: NCT02202369
Recruitment Status : Recruiting
First Posted : July 29, 2014
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Charlotte Orthopedic Hospital
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
Single Level Lumbar Decompression and Fusion Spine Surgery Other: Multimodal Analgesia Treatment Other: Standard of Care Pain Management Protocol Phase 4

Detailed Description:

Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.

Controlling postoperative pain is a critical first step in facilitating a patient's recovery and improved quality of life. In-hospital pain levels will be measured using a numeric pain scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard of care protocol. Assessments are every four to six hours, within 60 minutes after receiving a pain medication

Hypothesis: Patients treated with the MMA pain protocol will have significantly less immediate postoperative pain as compared to patients treated with the standard pain protocol.

Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.

Decreasing narcotic consumption following lumbar spinal fusion surgery is important for faster recovery for the patient, decreasing narcotic related side effects (nausea and vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount of narcotic use during the course of the hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents.

Hypothesis: Patients treated with the MMA pain protocol will consume significantly less immediate postoperative narcotic pain medications compared to patients treated with the standard pain protocol.

Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.

Decreasing the amount of time patients remain in the hospital may decrease the time it takes a patient to return to personal and societal responsibilities. Additionally it reduces the patients risk of a nosocomial infection and reduces the costs of the surgery.

Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced length of stay in the hospital compared to patients treated with the standard pain protocol.

Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.

The primary purpose of lumbar fusion surgery is to improve the quality of life for patients. The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient reported outcome measures will be collected pre-operatively and at each of the following postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.

Hypothesis: Patients treated with the MMA pain protocol will have significantly greater improvement in Quality of Life measures compared to patients treated with the standard pain protocol and this will be sustained out to two years post-operatively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
Study Start Date : February 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multimodal Analgesia (MMA) Treatment 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.

Active Comparator: Standard of Care Pain Managment Protocol 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)




Primary Outcome Measures :
  1. Patient reported pain level using a verbal numeric pain scale (NPS) [ Time Frame: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days) ]
    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.


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days) ]
    As part of the nurse driven standard of care protocol, patients are asked if their pain level is acceptable during their stay in the hospital

  2. Narcotic consumption [ Time Frame: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days) ]
    The total amount of narcotic use during the course of hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents

  3. Length of stay [ Time Frame: Hospital discharge (an expected average of 2 days after surgery) ]
    The number of hours of hospitalization from entering the recovery room (time zero) until the patient meets discharge criteria

  4. Discharge destination [ Time Frame: Hospital discharge (an expected average of 2 days after surgery) ]
    As standard of care this data point will be documented in the patients chart. It is categorized as patient home, rehabilitation facility, or skilled nursing facility

  5. Oswestry Disability Index (ODI) [ Time Frame: 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 ]
    A disease specific questionnaire

  6. The Veterans Rand 12 (VR-12) [ Time Frame: 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 ]
    A general health questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects undergoing a single level lumbar decompression and fusion
  2. > 18 years of age and < 70 years of age
  3. 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

Exclusion Criteria:

  1. Patients with liver disease (documented liver function test abnormality)
  2. Patients with renal disease (documented glomerular filtration rate < 60mL/min/1.73m2)
  3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.
  4. Patients with active alcohol dependence
  5. Patients with active illicit drug dependence
  6. Patients < 18 years of age and >70 years of age
  7. Patients allergic to any medication given in either arm (list medications)
  8. Patients who have a seizure disorder

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 ClinicalTrials.gov identifier (NCT number): NCT02202369


Contacts
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Contact: OrthoCarolina Research Institute

Locations
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United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, PhD    704-323-2265    Susan.Odum@OrthoCarolina.com   
Contact: Christi Cadd, MBA    704.323.2260    christi.cadd@orthocarolina.com   
Sub-Investigator: Bruce Darden, MD         
Sub-Investigator: Eric Laxer, MD         
Principal Investigator: Alden Milam, MD         
Sub-Investigator: Alfred Rhyne, MD         
Sub-Investigator: Bradley Segebarth, MD         
Sub-Investigator: Leo Spector, MD         
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Charlotte Orthopedic Hospital
Investigators
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Principal Investigator: Alden Milam, MD OrthoCarolina Research Institute, Inc.

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02202369     History of Changes
Other Study ID Numbers: 9080
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by OrthoCarolina Research Institute, Inc.:
Multimodal Analgesia
Pain Management