Study of Pain Control in Hemorrhoidectomy

NCT ID: NCT00890721

Last Updated: 2013-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

Brief Summary

Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.

Conditions

Hemorrhoid

Keywords

Hemorrhoid; Hemorrhoidectomy; Postoperative pain; Analgesia

Study Design

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

Study Groups

SKY0402

During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.

Group Type: EXPERIMENTAL

SKY0402

Intervention Type: DRUG

During the operation, 30cc of SKY0402 are injected into the wound.

Placebo

During the hemorrhoidectomy, 30cc Placebo injected into the wound.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

During the hemorrhoidectomy, 30cc Placebo injected into the wound.

Interventions

SKY0402

During the operation, 30cc of SKY0402 are injected into the wound.

Intervention Type: DRUG

Placebo

During the hemorrhoidectomy, 30cc Placebo injected into the wound.

Intervention Type: DRUG

Other Intervention Names

EXPAREL; saline 0.9%

Eligibility Criteria

Inclusion Criteria

• Age > 18 years of age at the Screening visit
• American Society of Anesthesiologists (ASA) class 1-3
• Scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique
• For female subjects, surgically sterile or at least two years menopausal, or using an acceptable method of birth control; must have a documented negative blood or urine pregnancy test within 24 hours before surgery
• Clinical lab values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator.
• Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
• Able to speak, read, and understand the language of all subject-facing documents, including the ICF and study questionnaires
• Able and willing to comply with all study visits and procedures

Exclusion Criteria

• Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component
• Body weight less than 50 kilograms (110 pounds)
• History of hypersensitivity or idiosyncratic reactions or amide-type local anesthetics, opioids, or propofol
• Current painful physical condition or concurrent surgery other than hemorrhoids that may require analgesic treatment (such as non-steroidal anti-inflammatory drug [NSAID], opioid, selective serotonin reuptake inhibitor [SSRI], tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the hemorrhoidectomy procedure and may confound the postoperative assessments
• Concurrent fissurectomy
• Use of any NSAID including selective COX-2 inhibitor, opioid, SSRI, tricyclic antidepressant, gabapentin, or pregabalin within three days of surgery
• Use of acetaminophen within 24 hours of surgery
• Chronic users 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
• History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
• Current use of glucocorticosteroids or use of glucocorticoids within one month of enrollment into this study
• HIV infection or hepatitis
• Currently pregnant, nursing, or planning to become pregnant during the course of the study or within one month of study drug administration
• Any psychiatric, psychological, medical, or laboratory condition that the investigator feels makes the subject an inappropriate candidate for this clinical trial
• Subjects who have received another investigational drug within the longer of the last 30 days or 10 elimination half-lives
• Previous participation in a SKY0402 study
• Failure to pass drug and alcohol screen

• 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

Zbigniew Śledziński, MD

Role: PRINCIPAL_INVESTIGATOR

General Surgery, Transplantology and Endocrinology Department, Gdansk

Locations

Prof. Zbigniew Śledziński

Gdansk, , Poland

Countries

Poland

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)

Other Identifiers

SKY0402C316

Identifier Type: -

Identifier Source: org_study_id