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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04522206
Other study ID # 20-00734
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 20, 2020
Est. completion date June 10, 2021

Study information

Verified date July 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 10, 2021
Est. primary completion date June 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 hours
Primary Opioid Sparing and Rescue Time Time interval from patient extubation to time when pain medication is first demanded in the PACU 24 hours
Secondary Length of Stay in Hospital Up to 12 days
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