Study of Postoperative Analgesia in Bunionectomy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00890682 |
Recruitment Status :
Completed
First Posted : April 30, 2009
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bunion Hallux Valgus | Drug: SKY0402 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 193 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing First Metatarsal Osteotomy (Bunionectomy) |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Sky0402
Injection of Study Drug
|
Drug: SKY0402
Local infiltration of 8cc SKY0402
Other Name: EXPAREL |
Placebo Comparator: Placebo
Injection of study drug
|
Drug: Placebo
Local infiltration of 8cc Placebo
Other Name: saline 0.9% |
- Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores [ Time Frame: 0-24 hours ]
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?"
- Adverse Event Profile [ Time Frame: 30 days ]Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890682
United States, Texas | |
Premier Research Group | |
Austin, Texas, United States, 78705 |
Principal Investigator: | Stephen Daniels, DO | Premier Research Group Clinical Research Center |
Responsible Party: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00890682 |
Other Study ID Numbers: |
SKY0402C317 |
First Posted: | April 30, 2009 Key Record Dates |
Results First Posted: | August 5, 2013 |
Last Update Posted: | August 5, 2013 |
Last Verified: | July 2013 |
Bunion Bunionectomy Osteotomy |
Hallux Valgus Bunion Foot Deformities Musculoskeletal Diseases Foot Deformities, Acquired |