Safety, Efficacy, and Pharmacokinetics of SKY0402 Administered as a Nerve Block in Subjects Undergoing Bunionectomy

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

Subjects were eligible for enrollment if they met the following criteria:

1. Males and females ≥18 years of age at the Screening Visit. NOTE: Eligible females were postmenopausal or surgically sterile, or, if of child bearing potential, were not pregnant or nursing, and they agreed to not become pregnant during the study by using acceptable means of contraception for at least 1 month before and 1 month after dosing, including any of the following: hormonal contraceptives (oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device (IUD), lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.

2. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair under general anesthesia, with or without internal fixation.

NOTE: For the purpose of this protocol, all surgical procedures involving osteotomy of the first metatarsal (significant bone resection, excision, surgical fracture, etc.) or fusion of the first metatarsal phalangeal joint were considered qualified procedures, whether or not performed specifically to repair a bunion (hallus valgus deformity). Surgical techniques accompanied by minimal bone excision (e.g. cheilectomy) or procedures limited to soft tissue repair were not eligible for this study.

3. American Society of Anesthesiology (ASA) Physical Class 1 or 2.

4. Able and willing to comply with all study visits and procedures.

5. Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales.

6. Willing and capable of providing written informed consent.

Exclusion Criteria:

Subjects were excluded from the study if they met any of the following criteria:

1. Clinically significant electrocardiogram (ECG) abnormalities at Screening or on Day 1 (before dosing).

2. Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.

3. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might have increased the risk of surgery or complicated the subject's postoperative course.

4. Opioid medication usage during the 7 day period preceding the administration of study drug.

5. Current medical conditions that could have required treatment with analgesic medications in the postoperative period for pain that was not surgically related (e.g., rheumatoid arthritis).

6. Body mass index >30 kg/m^2.

7. Body weight less than 60 kilograms.

8. History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic agents.

9. History of hypersensitivity, idiosyncratic reactions, and other contraindications to the pain control agents (opioid or non-opioid) anticipated to be used postoperatively. These contraindications may have included the following: angioedema and bronchospastic reactivity to non-steroidal anti-inflammatory drug (NSAID), peptic ulcer (active within the last 3 months), or hepatic or renal insufficiency.

10. Coagulation disorders or ongoing anticoagulation treatment.

11. Administration of an investigational drug within 30 days or 5 half lives (of elimination), whichever was longer, prior to study drug administration.

12. Suspected or known history of substance abuse and/or alcoholism.