Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03927911
Status:
TERMINATED
Last Update Posted:
2021-11-09
First Post:
2019-04-19
Brief Title:
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Sponsor:
Pacira Pharmaceuticals Inc
Organization:
Pacira Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Prospective Active Controlled Real World Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries FUSION
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to protocol feasibility given the rapid evolution of medical practice for spinal procedure Data from approximately 65 FUSION study subjects will be analyzed with the intent to create either a future study or registry for this patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUSION
Brief Summary:
Primary Objective The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia LIA with EXPAREL and bupivacaine HCl EXPAREL group with that of patients receiving standard of care SOC control group in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen
Secondary Objectives The secondary objectives of this study are to
1 Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride HCl versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours including time to first opioid and opioid-related adverse events ORAEs
2 Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride HCl versus SOC in adult subjects undergoing posterior lumbar spine surgeries including discharge readiness hospital or other facility length of stay LOS discharge disposition hospital readmissions and health service utilization
Secondary Objectives The secondary objectives of this study are to
1 Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride HCl versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours including time to first opioid and opioid-related adverse events ORAEs
2 Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride HCl versus SOC in adult subjects undergoing posterior lumbar spine surgeries including discharge readiness hospital or other facility length of stay LOS discharge disposition hospital readmissions and health service utilization
Detailed Description:
This is a Phase 4 multicenter prospective active-controlled real world study in approximately 225 adult subjects undergoing posterior lumbar spine surgery under general anesthesia
Subjects will be screened within 30 days prior to surgery screening on the day of surgery will be allowed but is discouraged If a subject can only be screened on the day of surgery the informed consent process must still be started at least 24 hours prior to the conduct of any screening procedures that are not considered SOC at the institution and such procedures may not be performed until written informed consent is provided All screening procedures that are not SOC must be performed and documented within the 30-day time window inclusive of the day of surgery for those subjects who can only be screened on the day of surgery as described here
During the screening visit subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation After the ICF is signed the following information will be recorded and procedures done medical history surgical history medication history the subjects opioid use history will be recorded to calculate mean daily mg oral morphine equivalent dosing MED PO in the last 30 days demographic and background information height weight and body mass index BMI a urine pregnancy test for women of childbearing potential and the subjects current adverse experiences AEs if any
Subjects will be asked questions andor be asked to fill forms as part of the following assessments Brief Pain Inventory - short form BPI-sf 5-item Opioid Compliance Checklist OCC Hospital Anxiety and Depression Scale HADS Survey of Pain Attitudes SOPA Numeric Rating Scale NRS ti assess pain and Opioid Related Symptom Distress Scale ORSDS
Based on the planned surgical procedure subjects will be placed in one of three cohorts
Cohort 1 - Open lumbar spinal fusion technique open cohort
Cohort 2 - Minimally invasive tubular andor percutaneous pedicle screw insertion for lumbar decompression with or without fusiontubularpercutaneous without midline incision cohort
Cohort 3 - Lumbar decompression surgery LDS without fusion discectomy or laminectomy outpatient cohort
The initial sample size in each study cohort ie cohort 1 cohort 2 and cohort 3 is estimated at 75 subjects 50 subjects with EXPAREL and 25 subjects with Control group for a total of 225 subjects in all three cohorts Within each assigned cohort subjects will be allocated in a 21 ratio to the EXPAREL 50 subjects and Control group 25 subjects
The following sequence will be followed for all cohorts First the subjects who meet eligibility criteria will be treated according to the institutions SOC Their data will be collected prospectively Next at each investigational site the administration of EXPAREL and bupivacaine HCl to the first 1 to 3 subjects in each cohort will be observed to ensure that the correct procedure for infiltration as described in the infiltration guide is being followed If the infiltration was performed correctly the subject will be included in the study If the infiltration was performed incorrectly the subject will continue in the study but will be removed from statistical analysis and will be replaced to ensure at least 50 evaluable EXPAREL patients are enrolled per cohort If subjects are discontinued for other reasons they will be replaced such that a total sample size of 75 fully evaluable subjects is obtained in each study cohort with 50 in the EXPAREL group and 25 in the Control group
Subjects will be screened within 30 days prior to surgery screening on the day of surgery will be allowed but is discouraged If a subject can only be screened on the day of surgery the informed consent process must still be started at least 24 hours prior to the conduct of any screening procedures that are not considered SOC at the institution and such procedures may not be performed until written informed consent is provided All screening procedures that are not SOC must be performed and documented within the 30-day time window inclusive of the day of surgery for those subjects who can only be screened on the day of surgery as described here
During the screening visit subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation After the ICF is signed the following information will be recorded and procedures done medical history surgical history medication history the subjects opioid use history will be recorded to calculate mean daily mg oral morphine equivalent dosing MED PO in the last 30 days demographic and background information height weight and body mass index BMI a urine pregnancy test for women of childbearing potential and the subjects current adverse experiences AEs if any
Subjects will be asked questions andor be asked to fill forms as part of the following assessments Brief Pain Inventory - short form BPI-sf 5-item Opioid Compliance Checklist OCC Hospital Anxiety and Depression Scale HADS Survey of Pain Attitudes SOPA Numeric Rating Scale NRS ti assess pain and Opioid Related Symptom Distress Scale ORSDS
Based on the planned surgical procedure subjects will be placed in one of three cohorts
Cohort 1 - Open lumbar spinal fusion technique open cohort
Cohort 2 - Minimally invasive tubular andor percutaneous pedicle screw insertion for lumbar decompression with or without fusiontubularpercutaneous without midline incision cohort
Cohort 3 - Lumbar decompression surgery LDS without fusion discectomy or laminectomy outpatient cohort
The initial sample size in each study cohort ie cohort 1 cohort 2 and cohort 3 is estimated at 75 subjects 50 subjects with EXPAREL and 25 subjects with Control group for a total of 225 subjects in all three cohorts Within each assigned cohort subjects will be allocated in a 21 ratio to the EXPAREL 50 subjects and Control group 25 subjects
The following sequence will be followed for all cohorts First the subjects who meet eligibility criteria will be treated according to the institutions SOC Their data will be collected prospectively Next at each investigational site the administration of EXPAREL and bupivacaine HCl to the first 1 to 3 subjects in each cohort will be observed to ensure that the correct procedure for infiltration as described in the infiltration guide is being followed If the infiltration was performed correctly the subject will be included in the study If the infiltration was performed incorrectly the subject will continue in the study but will be removed from statistical analysis and will be replaced to ensure at least 50 evaluable EXPAREL patients are enrolled per cohort If subjects are discontinued for other reasons they will be replaced such that a total sample size of 75 fully evaluable subjects is obtained in each study cohort with 50 in the EXPAREL group and 25 in the Control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None