Study of Postoperative Analgesia in Bunionectomy

NCT00890682 | Completed Phase 3 Results DMC

• 1 other identifier: SKY0402C317
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Bunion; Hallux Valgus

Keywords

Bunion; Bunionectomy; Osteotomy

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores

  The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"

  0-24 hours

Secondary Outcomes (1)

• Adverse Event Profile

  30 days

Study Arms (2)

Sky0402

EXPERIMENTAL

Injection of Study Drug

Drug: SKY0402

Placebo

PLACEBO COMPARATOR

Injection of study drug

Drug: Placebo

Interventions

SKY0402 DRUG

Local infiltration of 8cc SKY0402

Also known as: EXPAREL

Sky0402

Placebo DRUG

Local infiltration of 8cc Placebo

Also known as: saline 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Premier Research Group

Austin, Texas, 78705, United States

Location

Related Publications (2)

• 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.

  PMID: 22900785 DERIVED

• 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.

  PMID: 21842428 DERIVED

MeSH Terms

Conditions

Bunion; Hallux Valgus

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals, Inc

ErolOnel@pacira.com

203-837-6500

Study Officials

• Stephen Daniels, DO

  Premier Research Group Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 30, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 5, 2013
• Results First Posted: August 5, 2013

Record last verified: 2013-07

Locations

US (1)