Eligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision

Spinal Fusion

Pain Management

EXPAREL

University of Miami

The Ohio State University Wexner Medical Center

Thomas Jefferson University

PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery

A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Local Administration of EXPAREL When Administered for Prolonged Postsurgical Analgesia in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery

Pain intensity scores using the VAS at predose (on Day 1 prior to study drug administration); upon arrival at the post-anesthesia care unit (PACU); at 4, 8, 12, 24, 36, 48, 60, and 72 hours after the beginning of study drug administration; immediately prior to each administration of rescue pain medication; and just prior to hospital discharge

Pharmacokinetic parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis, based on the sampling schedule at predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7

Pacira Pharmaceuticals, Inc

Postoperative Pain Management

Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl

Bupivacaine HCl

Drug: EXPAREL EXPAREL and bupivacaine HCl
Other Name: bupivacaine liposome injectable suspension Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl

EXPAREL and bupivacaine HCl

OrthoArizona

St. Joseph's Hospital

UC Davis

Massachusetts General Hospital

Beaumont Health

Washington Univ

Icahn School of Medicine

OrthoCarolina

Ohio State Univ

Thomas Jefferson University of Neurosurgery

Central Texas Spine Institute

Baylor Scott & White

Univ of Virginia

Colonial Orthopaedics

West Virginia University Hospitals

Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

A Multicenter, Randomized, Double-Blind, Controlled Study of EXPAREL for Postsurgical Pain Management in Subjects Undergoing Open Lumbar Spinal Fusion Surgery

The AUC of the VAS pain intensity scores from 12-48 hours

total opioid consumption (in IV morphine equivalents) from 0-48 hours

A continuous intravenous infusion of lidocaine

A continuous intravenous infusion of saline

A continuous intravenous infusion of lidocaine
Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours

Lidocaine Infusion

A continuous intravenous infusion of saline
Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours

Saline Infusion

Total

Sex: Female, Male

Region of Enrollment

Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)

Intensity of Pain

The time to withdraw at the Cold Pressor Task immediately after 4-hours intravenous continuous lidocaine infusion

Withdrawal Time (Seconds)

Overall Study

Enas Kandil

Chronic Pain

Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours

Lidocaine infusion

A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours

hyperesthesia/seizures

PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery

Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients

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