Study of Postoperative Analgesia in Bunionectomy

NCT ID: NCT00890682

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-11-30

Brief Summary

After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.

Detailed Description

Following drug study administration, safety and efficacy assessments were conducted

Conditions

Bunion; Hallux Valgus

Keywords

Bunion; Bunionectomy; Osteotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sky0402

Injection of Study Drug

Group Type: EXPERIMENTAL

SKY0402

Intervention Type: DRUG

Local infiltration of 8cc SKY0402

Placebo

Injection of study drug

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Local infiltration of 8cc Placebo

Interventions

SKY0402

Local infiltration of 8cc SKY0402

Intervention Type: DRUG

Placebo

Local infiltration of 8cc Placebo

Intervention Type: DRUG

Other Intervention Names

EXPAREL; saline 0.9%

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years at the Screening visit
• Scheduled to undergo primary unilateral first metatarsal osteotomy without hammertoe
• Female subjects must be surgically sterile or at least two years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours before surgery
• Clinical laboratory values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator
• Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments

Exclusion Criteria

• Currently pregnant, nursing, or planning to become pregnant during the study or within one month after study drug administration
• Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
• Use of any non-steroidal anti-inflammatory drug (NSAID) including selective COX-2 inhibitor within three days of surgery
• Use of acetaminophen within 24 hours of surgery
• Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) within three days of surgery
• Current use of systemic glucocorticosteroids or use of systemic glucocorticoids within one month of enrollment into this study
• Peripheral neuropathy including diabetic neuropathy, chemotherapy-induced neuropathy, HIV neuropathy
• History of hepatitis
• History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
• Failure to pass urine drug screen
• Current evidence of alcohol abuse (greater than 4 units of alcohol per day: 1 unit = ½ pint of beer, 1 glass of wine or 1 oz. of spirits)
• Evidence of peripheral ischemic disease
• Type I or Type II diabetes
• Current acute or chronic medical or major psychiatric disease that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety
• 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
• Administration of an investigational drug within 30 days 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 SKY0402 study
• Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures
• Current painful physical conditions or concurrent surgery other than bunionectomy that may require analgesic treatment (such as NSAID or opioid) in the postoperative period for pain that is not strictly related to the bunionectomy procedure and may confound the postoperative assessments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Daniels, DO

Role: PRINCIPAL_INVESTIGATOR

Premier Research Group Clinical Research Center

Locations

Premier Research Group

Austin, Texas, United States

Countries

United States

References

Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

Reference Type: DERIVED

PMID: 22900785 (View on PubMed)

Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.

Reference Type: DERIVED

PMID: 21842428 (View on PubMed)

Other Identifiers

SKY0402C317

Identifier Type: -

Identifier Source: org_study_id