Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Postoperative Pain

In brief

The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2. Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).

Key facts

Study ID

NCT01683071

Run by

Pacira Pharmaceuticals, Inc

People needed

297

Starts

2012-09-01

Expected to finish

2013-12-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, >=18 years of age.
• Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
• American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3.
• Able to demonstrate motor function by performing a 20-meter walk, unassisted with the optional use of a 4-legged walker, and sensory function by exhibiting sensitivity to cold.
• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

You may not qualify if…

• Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control.
• If of childbearing potential, must have a documented negative pregnancy test within 24 hours before surgery.
• Planned concurrent surgical procedure (e.g., bilateral TKA).
• Use of any of the following medications within the times specified before surgery:
• long-acting opioid medication, NSAIDs, aspirin (except for low-dose aspirin used for cardioprotection) or acetaminophen within 3 days, or and any opioid medication within 24 hours.
• Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the surgical site administered study treatment, and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, prior contralateral TKA, concurrent foot surgery).
• Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinepherine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®).
• Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
• Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 40 kg/m2.
• Contraindication to hydromorphone, oxycodone, or bupivacaine.
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
• Previous participation in a liposome bupivacaine study.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Failure to pass the urine drug screen.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance.
• Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
• Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.
• Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
• Subjects who are planned to receive Entereg® (alvimopan).
• Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without regard to the subject's emesis needs.
• Use of dexmedetomidine HCl (Precedex®) within 3 days of surgery.

Where it is running

• ACHIEVE CLINICAL RESEARCH LLC 2017 Canyon Road Suite 41 — Birmingham, Alabama, United States
• HORIZON RESEARCH GROUP INC 3610 Springhill Memorial Dr. N — Mobile, Alabama, United States
• Veritas Research, LLC — Mobile, Alabama, United States
• SHOALS MEDICAL TRIALS INC. 1300 S Montgomery Ave — Sheffield, Alabama, United States
• PHOENIX ORTHOPAEDIC SURGEONS 2525 W. Greenway Road Suite 114 — Phoenix, Arizona, United States
• ALLIANCE RESEARCH CENTERS 24411 Health Center Drive Suite 350 — Laguna Hills, California, United States
• ORTHOPADIC SURGERY Loma Linda University Health Care Dept. Pf Orthopaedic Surgery 250 East Caroline Street Suite A — San Bernardino, California, United States
• University of California, San Diego — San Diego, California, United States
• Ilfeld, Brian (Thornton) UNIVERSITY OF CALIFORNIA, SAN DIEGO 10610 Hunters Glen Drive — San Diego, California, United States
• FLORIDA RESEARCH ASSOCIATES, LLC / FLORIDA ORTHOPAEDIC ASSOCIATES 740 W. Plymouth Ave — DeLand, Florida, United States
• JACKSON MEMORIAL HOSPITAL UNVERSITY OF MIAMI 1611 Nw. 12th Ave C300 — Miami, Florida, United States
• PENSACOLA RESEARCH CONSULTANTS,INC 5149 N.9th Avenue Suite 241 — Pensacola, Florida, United States
• SHERIDAN CLINICAL RESEARCH, INC. 1613 N. Harrison Parkway Building C Suite 200 — Sunrise, Florida, United States
• PHOENIX CLINICAL RESEARCH,LLC 7171 N. University Drive Suite 100 — Tamarac, Florida, United States
• UNIVERSITY OF KANSAS HOSPITAL & MEDICAL CENTER Dept. Of Anesthesiology 3901 Rainbow Blvd. Ms 1034 — Kansas City, Kansas, United States
• BEAUMONT HEALTH SYSTEM 44201 Dequindre Road Suite Pob 120 — Troy, Michigan, United States
• COOPER UNIVERSITY HOSPITAL 1 Cooper Plaza 202 Dorrance Building — Camden, New Jersey, United States
• UNIVERSITY OF MEDICINE AND DENSITRY OF NEW JERSEY/NEW JERSEY MEDICAL SCHOOL 185 South Orange Ave. Department of Anesthesiology - MSB E538 — Newark, New Jersey, United States
• NORTHERN WESTCHESTER HOSPTIAL Department Of Clinical Trials 400 East Main St. — Mount Kisco, New York, United States
• ST. LUKE-ROOSEVELT HOSPITAL CENTER Dept. Of Anesthesiology 1111 Amsterdam Ave. Travis Bld. 7 — New York, New York, United States
• INSALL-SCOTT-KELLY INSTITUTE 210 East 64th Street — New York, New York, United States
• UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL Department Of Anesthesiology 101 Manning Drive N0021, Cb 7010 — Chapel Hill, North Carolina, United States
• CLEVELAND CLINIC FAIRVIEW HOSPTIAL 1801 Lorain Avenue — Cleveland, Ohio, United States
• CLEVELAND CLINIC 9500 Euclid Ave P-77 — Cleveland, Ohio, United States
• PENN STATE MILTON S. HERSHEY MEDICAL CENTER H187,500 University Drive — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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