NCT03076710

Post-Operative Pain Management Following Spine Surgery

Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will assess the feasibility of the methods proposed, including recruitment, eligibility, standardization of both post-operative pain management approaches, and assessment of clinical, hospital efficiency, medication use, health services use, and economic outcomes.

Conditions

• Pain Management
• Analgesia
• Anesthetic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-31
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2017-03-10
• Last updated: 2020-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study