Post-Operative Pain Management Following Spine Surgery

Analgesia Clinical Trial

— EXPAREL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03076710
• Other study ID #: 20140496
• Status: Withdrawn
• Start date: July 31, 2017
• Est. completion date: March 2022

Study information

• Verified date: June 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthetic
• Pain Management
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity at the site of surgery	Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).	4 hours post surgery