CompletedPhase 2

Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty

United States138 participantsStarted 2007-06

Plain-language summary

Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, greater than or equal to 18 and less than or equal to 75 years of age at the Screening Visit.
✓. Female subjects only: Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
✓. Scheduled to undergo primary unilateral total knee arthroplasty (TKA) under general anesthesia.
✓. American Society of Anesthesiology (ASA) Physical Class 1-3.
✓. Able and willing to comply with all study visits and procedures.
✓. Able to speak, read, and understand the language of the Informed Consent, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.
✓. Willing and capable of providing written informed consent.

Exclusion criteria

✕. Pregnancy, nursing, or planning to become pregnant during the study or within one month after dosing.
✕. Use of any of the following medications within the times specified before surgery:
✕. Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site administered study treatment, and which may confound the postoperative assessments (e.g., significant pain from other joints, chronic neuropathic pain, concurrent contralateral TKA, concurrent foot surgery, etc.).
✕. Body weight less than 50 kilograms (110 pounds) or morbid obesity.
✕. Contraindication to any of the pain-control agents planned for postoperative use (e.g., acetaminophen, morphine, oxycodone, ketorolac).
✕. Contraindication to epinephrine, such as concurrent administration of monoamine oxidase (MAO) inhibitors or antidepressants of amitriptyline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine.
✕. 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.
✕. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

What they're measuring

Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4

Timeframe: 0 to 96 hours

Trial details

NCT IDNCT00485693

SponsorPacira Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2011-11-23

View on ClinicalTrials.gov More Postoperative Pain trials