Pain ManagementEXPARELNCT03076710
Post-Operative Pain Management Following Spine Surgery
An observational study of Pain Management and Analgesia, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Analgesia, Anesthetic
- What is being tested?
- Opioids delivered through PCA and EXPAREL® infiltration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing primary, single level, lumbar fusion surgical procedures.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Opioids delivered through PCA, EXPAREL® infiltration
- Keywords
- spine surgery, post-operative pain, patient controlled analgesia, Exparel®, bupivacaine
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioids delivered through PCADrug
IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours
EXPAREL® infiltrationDrug
Also called Bupivacaine, Marcaine
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
| Study group | Role | What they receive |
|---|---|---|
| Opioids delivered through PCA | PCA devices used to deliver opioids Receives: Drug: Opioids delivered through PCA | |
| EXPAREL® infiltration | EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed Receives: Drug: EXPAREL® infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity at the site of surgery
Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).
Measured: 4 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start31 Jul 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: No participants were identified per inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Steven Vanni, University of Miami
- Investigators
- Steven Vanni, DO, DC, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076710
- Sponsor's protocol ID
- 20140496
- Acronym
- EXPAREL
- Status last verified
- Jun 2020
- First submitted
- 24 Feb 2017
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery
- ClinicalTrials.gov ID
- NCT03076710
- Acronym / sponsor ID
- EXPAREL / 20140496
- Conditions
- Pain Management, Analgesia, Anesthetic
- Keywords
- spine surgery, post-operative pain, patient controlled analgesia, Exparel®, bupivacaine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were identified per inclusion/exclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioids delivered through PCA | – | Drug: Opioids delivered through PCAPCA devices used to deliver opioids |
| EXPAREL® infiltration | – | Drug: EXPAREL® infiltrationEXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary, single level, lumbar fusion surgical procedures.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioids delivered through PCAIV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours | Drug | Opioids delivered through PCA |
| EXPAREL® infiltrationAlso: Bupivacaine, Marcaine22 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 | Drug | EXPAREL® infiltration |
Primary outcome
Pain severity at the site of surgery
Time frame: 4 hours post surgery
Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Vanni, DO, DC principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Analgesia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity at the site of surgery (time frame: 4 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.