Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03015961
Status:
TERMINATED
Last Update Posted:
2021-10-13
First Post:
2016-11-14
Brief Title:
Phase 4 Controlled Study in Adult Subjects Undergoing Primary 1-2 Level Open Lumbar Spinal Fusion Surgery
Sponsor:
Pacira Pharmaceuticals Inc
Organization:
Pacira Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Controlled Study of EXPAREL for Postsurgical Pain Management in Subjects Undergoing Open Lumbar Spinal Fusion Surgery
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery
Secondary Objectives The secondary objectives of this study are to compare additional efficacy safety and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery
Secondary Objectives The secondary objectives of this study are to compare additional efficacy safety and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery
Detailed Description:
This is a Phase 4 multicenter randomized double-blind controlled study in 38 adult subjects undergoing primary 1-2 level open lumbar spinal fusion surgery under general anesthesia
Subjects will be screened within 30 days prior to study drug administration and at least one day prior to surgery During the screening visit subjects will be assessed for past or present neurologic cardiac and general medical conditions that in the opinion of the Investigator would preclude them from study participation After the informed consent form ICF is signed a medical history surgical history physical examination 12-lead electrocardiogram ECG vital sign measurements select clinical laboratory evaluations urine drug screen alcohol breath test and urine pregnancy test for women of childbearing potential will be conducted Study drug approximately 1-2 mL every 10-15 cm will be administered using 20- or 22-gauge needles prior to wound closure
Administration InstructionsProcedures
Study drug should be injected in the prescribed locations based on the areas of highest nerve density Study drug will be administered using syringes with 20- or 22-gauge needles prior to wound closure The Investigator must document the size of the incision Each infiltration site should be spaced 10-15 cm apart and should deliver approximately 1-2 mL into both deep and superficial areas para-spinous fascia muscle and subcutaneous layers Total volume administered will be depended on the number of levels of dissection as described below Following infiltration the tissue should visibly expand with minimal leakage
Total Volume of Expansion
The Investigator must document the total volume used for each surgery
1 Level Procedures Group 1 EXPAREL 266 mg in 20 mL bupivacaine HCl 05 in 20 mL 20 mL normal saline total volume of 60 mL Group 2 Bupivacaine HCl 05 in 20 mL 40 mL normal saline total volume of 60 mL
2 Level Procedures Group 1 EXPAREL 266 mg in 20 mL bupivacaine HCl 05 in 20 mL 50 mL normal saline total volume of 90 mL Group 2 Bupivacaine HCl 05 in 20 mL 70 mL normal saline total volume of 90 mL
Drains may be used at the surgeons discretion In addition to LIA all study participants will receive a standardized approach for managing postsurgical pain that includes a scheduled multimodal pain regimen including adjunctive analgesics non-steroidal anti-inflammatory drugs NSAIDs Rescue analgesics will be available as needed
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale VAS see Appendix 1 overall benefit of analgesia score OBAS questionnaire see Appendix 2 total postsurgical opioid consumption predefined opioid-related AEs and nurses satisfaction with overall analgesia see Appendix 3
Adverse events will be recorded from the time the ICF is signed through Day 30 If a cardiac AE eg chest pain angina myocardial infarction abnormalirregular heart rate bradycardia tachycardia extrasystoles or shortness of breath neurological AE eg altered mental statusaltered sensorium dizziness dysarthria hyperesthesia metallic taste peroral numbness seizure tinnitus tremors visual disturbance muscular twitching or rigidity beyond 72 hours postdose or tinglingparesthesia beyond 72 hours postdose or serious AE SAE occurs during the study a 12-lead ECG vital signs and any appropriate clinical laboratory tests should be conducted
Postsurgical health economic outcome assessments will include hospital length of stay LOS use of skilled nursing facility hospital readmissions and use of other health services following discharge phone calls related to postsurgical pain unscheduled visits related to postsurgical pain and visits to emergency department through Day 30
A follow-up visit will be scheduled for all subjects on postsurgical Day 14 A follow-up phone call will be made on Day 30 to all subjects who received study drug to assess for adverse events AEs
Number of Subjects Planned
Approximately 194 subjects are planned for enrollment in this study in order to have at least 184 evaluable subjects
Subjects will be screened within 30 days prior to study drug administration and at least one day prior to surgery During the screening visit subjects will be assessed for past or present neurologic cardiac and general medical conditions that in the opinion of the Investigator would preclude them from study participation After the informed consent form ICF is signed a medical history surgical history physical examination 12-lead electrocardiogram ECG vital sign measurements select clinical laboratory evaluations urine drug screen alcohol breath test and urine pregnancy test for women of childbearing potential will be conducted Study drug approximately 1-2 mL every 10-15 cm will be administered using 20- or 22-gauge needles prior to wound closure
Administration InstructionsProcedures
Study drug should be injected in the prescribed locations based on the areas of highest nerve density Study drug will be administered using syringes with 20- or 22-gauge needles prior to wound closure The Investigator must document the size of the incision Each infiltration site should be spaced 10-15 cm apart and should deliver approximately 1-2 mL into both deep and superficial areas para-spinous fascia muscle and subcutaneous layers Total volume administered will be depended on the number of levels of dissection as described below Following infiltration the tissue should visibly expand with minimal leakage
Total Volume of Expansion
The Investigator must document the total volume used for each surgery
1 Level Procedures Group 1 EXPAREL 266 mg in 20 mL bupivacaine HCl 05 in 20 mL 20 mL normal saline total volume of 60 mL Group 2 Bupivacaine HCl 05 in 20 mL 40 mL normal saline total volume of 60 mL
2 Level Procedures Group 1 EXPAREL 266 mg in 20 mL bupivacaine HCl 05 in 20 mL 50 mL normal saline total volume of 90 mL Group 2 Bupivacaine HCl 05 in 20 mL 70 mL normal saline total volume of 90 mL
Drains may be used at the surgeons discretion In addition to LIA all study participants will receive a standardized approach for managing postsurgical pain that includes a scheduled multimodal pain regimen including adjunctive analgesics non-steroidal anti-inflammatory drugs NSAIDs Rescue analgesics will be available as needed
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale VAS see Appendix 1 overall benefit of analgesia score OBAS questionnaire see Appendix 2 total postsurgical opioid consumption predefined opioid-related AEs and nurses satisfaction with overall analgesia see Appendix 3
Adverse events will be recorded from the time the ICF is signed through Day 30 If a cardiac AE eg chest pain angina myocardial infarction abnormalirregular heart rate bradycardia tachycardia extrasystoles or shortness of breath neurological AE eg altered mental statusaltered sensorium dizziness dysarthria hyperesthesia metallic taste peroral numbness seizure tinnitus tremors visual disturbance muscular twitching or rigidity beyond 72 hours postdose or tinglingparesthesia beyond 72 hours postdose or serious AE SAE occurs during the study a 12-lead ECG vital signs and any appropriate clinical laboratory tests should be conducted
Postsurgical health economic outcome assessments will include hospital length of stay LOS use of skilled nursing facility hospital readmissions and use of other health services following discharge phone calls related to postsurgical pain unscheduled visits related to postsurgical pain and visits to emergency department through Day 30
A follow-up visit will be scheduled for all subjects on postsurgical Day 14 A follow-up phone call will be made on Day 30 to all subjects who received study drug to assess for adverse events AEs
Number of Subjects Planned
Approximately 194 subjects are planned for enrollment in this study in order to have at least 184 evaluable subjects
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?:
None
Is an FDA AA801 Violation?:
None