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An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery

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ClinicalTrials.gov Identifier: NCT04522206
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Spine Injuries and Disorders Narcotic Use Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective cohort study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Actual Study Start Date : August 20, 2020
Actual Primary Completion Date : June 10, 2021
Actual Study Completion Date : June 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients undergoing elective spine surgery Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone

The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of:

Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release





Primary Outcome Measures :
  1. Score on VAS pain scale in PACU [ Time Frame: 24 hours ]
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

  2. Opioid sparing and rescue time [ Time Frame: 24 hours ]
    Time interval from patient extubation to time when pain medication is first demanded in PACU


Secondary Outcome Measures :
  1. Length of stay in PACU [ Time Frame: 24 hours ]
  2. Opioid dose [ Time Frame: 24 hours ]
  3. Transfusion rates [ Time Frame: 24 hours ]
  4. Surgical Drain output in mL [ Time Frame: 24 hours ]
  5. Hospital length of stay [ Time Frame: 5-7 Days ]


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:

  • Undergoing elective spine surgery at NYU Winthrop
  • Age over 18 years

Exclusion Criteria:

  • History of neuromuscular disorders
  • History of inflammatory arthropathies
  • History of spine metastases or active cancer in spine
  • Medical History including any of the following: renal dysfunction, gastric ulcers, hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic reactions to any of the medications in the study
  • Age less than 18 years

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): NCT04522206


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Muhammad Tariq, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04522206    
Other Study ID Numbers: 20-00734
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria: Requests may be directed to the PI.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents