Post-Operative Pain Management Following Spine Surgery
| Status: | Recruiting | 
|---|---|
| Conditions: | Chronic Pain, Post-Surgical Pain | 
| Therapuetic Areas: | Musculoskeletal | 
| Healthy: | No | 
| Age Range: | 18 - 65 | 
| Updated: | 12/16/2018 | 
| Start Date: | July 31, 2017 | 
| End Date: | March 2022 | 
| Contact: | Karthik Madhavan, MBBS | 
| Email: | karthik.madhavan@jhsmiami.org | 
| Phone: | 3052436946 | 
Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery
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.
			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.
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.
eligibility, standardization of both post-operative pain management approaches, and
assessment of clinical, hospital efficiency, medication use, health services use, and
economic outcomes.
Inclusion Criteria:
- Age 18-65
- Ability to speak, read, and write in English or Spanish
- Primary indication is low back pain, radiculopathy, disc degeneration, disc
herniation, foraminal stenosis, or mild 1-level spondylolisthesis or deformity
- Scheduled to undergo primary, single level, lumbar fusion surgical procedure at the
study center in the next 30 days
- Willing to provide informed consent, participate in study, and comply with study
protocol
Exclusion Criteria:
- Body mass index >35
- Pregnant or contemplating pregnancy prior to surgery
- Current or previous psychiatric, behavioral, or emotional disorder that may interfere
with postsurgical pain, analgesia, or opioid use according to treating surgeon
- Prior treatment for alcohol, recreational drug, or opioid abuse
- Chronic inflammatory conditions (e.g. Crohn's, lupus, rheumatoid arthritis)
- Chronic neurologic conditions (e.g. multiple sclerosis, Parkinson's)
- Serious spinal conditions (e.g. cauda equina syndrome, infection, tumor, fracture)
- Hypersensitivity or allergy to local anesthetics
- Previous surgery in lumbar spine (i.e. other than microdiscectomy);
- Continuous (e.g. daily) opioid consumption for more than 30 days prior to surgery
We found this trial at
    1
    site
	
									1400 NW 12th Ave
Miami, Florida 33136
	
			Miami, Florida 33136
(305) 689-5511
							
					Principal Investigator: Steven Vanni, DO, DC
			
						
								
		University of Miami Hospital The University of Miami changed the face of modern health care...  
  
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