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
Primary Purpose
Pain, Postoperative, Spine Injuries and Disorders, Narcotic Use
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing elective spine surgery
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) for Pain
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Opioid Sparing and Rescue Time
Time interval from patient extubation to time when pain medication is first demanded in the PACU
Secondary Outcome Measures
Length of Stay in Hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04522206
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Spine Injuries and Disorders, Narcotic Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
A prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing elective spine surgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
Intervention Description
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 Measure Information:
Title
Visual Analogue Scale (VAS) for Pain
Description
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time Frame
24 hours
Title
Opioid Sparing and Rescue Time
Description
Time interval from patient extubation to time when pain medication is first demanded in the PACU
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Length of Stay in Hospital
Time Frame
Up to 12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Tariq, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Requests may be directed to the PI.
Learn more about this trial
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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