Study of Pain Control in Hemorrhoidectomy

NCT00890721 | Completed Phase 3 Results

• 1 other identifier: SKY0402C316
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.

  To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond 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?"

  72 hours

Secondary Outcomes (1)

• Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days

  30 days

Study Arms (2)

SKY0402

EXPERIMENTAL

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

Drug: SKY0402

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SKY0402 DRUG

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

Also known as: EXPAREL

SKY0402

Placebo DRUG

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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Prof. Zbigniew Śledziński

Gdansk, Poland

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative; Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System 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

• Zbigniew Śledziński, MD

  General Surgery, Transplantology and Endocrinology Department, Gdansk

  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: May 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 6, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-07

Locations

PL (1)