Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Hemorrhoids Clinical Trial

Official title:

Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744848
• Other study ID #: SIMPLE Hemorrhoidectomy 312
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2008
• Last updated: July 3, 2013
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2013
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Description:

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female equal or greater than 18 years of age at Screening

• Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.

• Scheduled to undergo 2-or3-column excisional hemorrhoidectomy

• American Society of Anesthesiology (ASA) Physical Class 1-4

• Able and willing to complete with all study visits and procedures

• Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments

• Willing and capable of provide written informed consent.

Exclusion Criteria:

• Pregnant, nursing or planning to become pregnant during the study period

• Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.

• Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.

• Single-column hemorrhoidectomy

• Body weight less than 50 kg (110 pounds)

• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)

• contraindication to epinephrine

• contraindication to any of the pain-control agents planned for postoperative use

• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration

• History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.

• Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.

• Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.

• Any clinically significant event or condition uncovered during surgery

• A cumulative incision length less than 3 cm

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• Bupivacaine HCl
100 mg Bupivacaine HCl
• SKY0402
Single administration 300 mg SKY0402 in a 40-mL injection volume

Locations

Country	Name	City	State
United States	Research Concepts, Ltd	Bellaire	Texas
United States	West Alabama Research Inc.	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Univ. Hospitals of Cleveland, Case Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	CTMG, Inc. - Pitt Medical Center	Greenville	North Carolina
United States	Medical Center Ambulatory Surgery Center	Houston	Texas
United States	The Women's Hospital of Texas	Houston	Texas
United States	Indiana University - Wishard Memorial Hospital	Indianapolis	Indiana
United States	Holston Medical Group	Kingsport	Tennessee
United States	University of Louisville	Louisville	Kentucky
United States	Drug Research and Analysis Corporation	Montgomery	Alabama
United States	Mount Sinai Hospital	New York	New York
United States	Colon and Rectal Disease Center	Orlando	Florida
United States	Lotus Clinical Research - Huntington Memorial Hospital	Pasadena	California
United States	Roland Saenz	San Antonio	Texas
United States	Accurate Clinical Trials	San Clemente	California
United States	UCSD Medical Center	San Diego	California
United States	University of Illinois	Springfield	Illinois
United States	Multicare Health System	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores	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. The subject was to rest in this position 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?"	through 96 hours	No
Secondary	Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30		through day 30	Yes