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Post-Operative Pain Management Following Spine Surgery

NCT03076710 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-07-02

No results posted yet for this study

Summary

The primary objective of this pilot study is to assess the feasibility of comparing two standardized approaches to manage post-operative pain following spine surgery: one approach using Patient Controlled Analgesia (PCA) devices to deliver opioid analgesics, and the other approach using EXPAREL® infiltration at the site of surgery and nurse-administered opioid analgesics.

Conditions

  • Pain Management
  • Analgesia
  • Anesthetic

Interventions

DRUG

Opioids delivered through PCA

IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours

DRUG

EXPAREL® infiltration

22 gauge / 3.5" needle, into dermal/fascial/muscular/subcutaneous layers and up to 4mg IV morphine every 60 minutes on request and standardized oral opioids on request

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Steven Vanni, DO, DC · University of Miami

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076710 on ClinicalTrials.gov