Clinical Trials Logo
  1. Home
  2. Postoperative Pain Management
  3. NCT03485014

Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

Postoperative Pain Management Clinical Trial

Official title:
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Local Administration of EXPAREL for Postsurgical Analgesia in Pediatric Subjects 12 to Less Than 17 Years of Age

Clinical Trial Summary

Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery. Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.

Clinical Trial Description

This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXAPREL when administered intraoperatively at the end of surgery via local infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal surgeries are planned for enrollment. Subjects will be screened within 30 days prior to study drug administration. 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. Subjects will undergo their pre-planned spinal surgeries per the institution's standard of care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg intraoperatively at the end of surgery via local infiltration into the surgical site. There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician. A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who received study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03485014
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 1
Start date April 10, 2018
Completion date February 12, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT02516059 - Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia Phase 4
Terminated NCT01736358 - The Use of Intranasal Ketoralac for Pain Management (Sprix) Phase 4
Completed NCT00806806 - Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers Phase 1
Terminated NCT02143141 - Low Pain Prediction in Cesarean Section Patients Phase 4
Recruiting NCT05011084 - Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery N/A
Terminated NCT03428984 - Study in Adult Subjects Undergoing Posterolateral Thoracotomy Phase 1
Completed NCT04371341 - A Comparative Study Between Different Volumes During Erector Spinae Block for Pain Control N/A
Recruiting NCT06298370 - The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty N/A
Completed NCT06028061 - Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant N/A
Completed NCT05401916 - Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery N/A
Terminated NCT03927911 - Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries Phase 4
Completed NCT01344213 - Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine Phase 4
Completed NCT04434339 - Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery N/A
Recruiting NCT02997215 - Intravenous Lidocaine and Postoperative Pain Management Phase 4
Completed NCT01070108 - Escalating Ketamine Doses and Pre-emption N/A
Not yet recruiting NCT06148168 - Magnesium Sulphate in Oblique Subcostal TAP Block Phase 2/Phase 3
Terminated NCT03015961 - Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery Phase 4
Completed NCT01726686 - Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump Phase 4
Not yet recruiting NCT04525963 - The Effect of Operating Room Nurse Visit Prior to Cardiac Surgery on Patients's Anxiety, Pain and Analgesic Use N/A
Completed NCT03437707 - Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery N/A