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Surgical Pain After Inguinal Hernia Repair (SPAIHR)

Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hernia, Inguinal; Pain, Postoperative

Intervention: Pregabalin (Drug); placebo (Drug); Pregabalin (Drug); Pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.

Clinical Details

Official title: A Randomized, Double Blind Multi Center Dose Ranging Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Adjunctive Treatment Of Post Surgical Pain After Primary Inguinal Hernia Repair

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the worst pain reported by subjects (question 1 of the Modified Brief Pain Inventory - short form) on the first day (approximately 24 hours) after the surgery is completed.

Secondary outcome:

The time in hours after surgery to first rescue medication use.

Numerical Rating Scale - Average Pain

Daily Sleep Interference Rating Scale

Pre specified adverse events of wound healing complications

All serious adverse events (SAEs), all treatment emergent adverse events (AEs)

Health status using EuroQol (EQ 5D) Health State Profile and the twelve item version of the short form acute health form (SF 12v2)

Relationship between baseline and postoperative Pain Catastrophizing Scale (PCS) score and severity of acute pain and to response to therapy.

Incidence of chronic post operative pain at 1, 3, and 6 months following surgery and the characteristics of the pain in those subjects reporting it (mBPI sf, NPSI).

Vital signs and clinical laboratory parameters

Numerical Rating Scale - Current Pain

Physician contacts to be collected by anesthesiologist, surgeon, or site staff 24 h and 72 hours post discharge using Physician Contact questions (PC)

Global Evaluation of Study Medication

The amount of opioids used during and following surgery.

Opioid Related Symptom Distress Scale

The amounts of non opioid rescue medication (naproxen) used by the subjects during the study, including anti emetic medications

Clinical Assessment of Pain With Movement

Time from end of surgery to PACU discharge.

Anxiety (VAS) before and after the surgery.

Time from the end of surgery (last stitch), to reach a score of 9 on post anesthetic discharge score system total (PADS).

Eligibility

Minimum age: 17 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- The subject will have elective ( the subject chooses, but does not have to undergo

surgery for an emergency) open unilateral inguinal herniorraphy (hernia repair), using mesh Lichtenstein surgery procedure and under general anesthesia and fentanyl or sufentanil/propofol initiation and sevoflurane or isoflurane maintenance plus local anesthetic infiltration at the conclusion of surgery. Study surgery should be anticipated to be in the morning.

- Expected to be able to use and tolerate non-steroidal anti-inflammatory drugs (such as

naproxen), tramadol, oxycodone, and acetaminophen/paracetamol for pain control after surgery.

- The subject will be available for a visit within 72 hours of the day of surgery if not

admitted the night before for baseline assessments before taking any study medication, and then to receive study medication prior to the day before surgery.

- The subject is expected and agrees to remain at the hospital (or intermediate care

facility) for a minimum of 3 hours following surgery.

Exclusion Criteria:

- Subjects with non elective or emergency surgery (must have the surgery no matter

what), or hernia with incarceration (the trapping of abdominal contents within the hernia itself).

- Subjects with hernia repair that is not a primary repair. The planned use of nerve

block or spinal/epidural/paravertebral anesthesia or surgery is not planned with general anesthesia.

- Subjects that are not allowed to receive the anesthesia agents indicated per protocol

and general anesthesia.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Westmead NSW 2145, Australia; Not yet recruiting

Pfizer Investigational Site, Quebec G1V 4G2, Canada; Recruiting

Pfizer Investigational Site, BARCELONA 08036, Spain; Recruiting

Pfizer Investigational Site, MADRID 28006, Spain; Recruiting

Pfizer Investigational Site, MADRID 28031, Spain; Recruiting

Pfizer Investigational Site, Orebro 701 85, Sweden; Recruiting

Pfizer Investigational Site, Gävle 801-87, Sweden; Recruiting

Pfizer Investigational Site, Landskrona 261 24, Sweden; Recruiting

Pfizer Investigational Site, Skelleftea 931 86, Sweden; Recruiting

Pfizer Investigational Site, Mora SE-792 85, Sweden; Recruiting

Pfizer Investigational Site, Birmingham, Alabama 35235, United States; Recruiting

Pfizer Investigational Site, Pasadena, California 91105, United States; Recruiting

Pfizer Investigational Site, Marietta, Georgia 30060, United States; Not yet recruiting

Pfizer Investigational Site, Baroda, Gujarat 390001, India; Recruiting

Pfizer Investigational Site, Pune, Maharashtra 411011, India; Recruiting

Pfizer Investigational Site, ROCHESTER, Minnesota 55902, United States; Recruiting

Pfizer Investigational Site, Rochester, Minnesota 55905, United States; Recruiting

Pfizer Investigational Site, Stony Brook, New York 11794-8480, United States; Recruiting

Pfizer Investigational Site, Rochester, New York 14642, United States; Recruiting

Pfizer Investigational Site, Durham, North Carolina 27710, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43210, United States; Recruiting

Pfizer Investigational Site, London, Ontario N6A 4V2, Canada; Recruiting

Pfizer Investigational Site, London, Ontario N6A 5A5, Canada; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15232, United States; Recruiting

Pfizer Investigational Site, Charlottetown, Prince Edward Island C1A 8T5, Canada; Recruiting

Pfizer Investigational Site, Knoxville, Tennessee 27920, United States; Recruiting

Pfizer Investigational Site, Knoxville, Tennessee 37920, United States; Recruiting

Pfizer Investigational Site, Nashville, Tennessee 37203, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75390-7208, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77024, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77054, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77098, United States; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2007
Ending date: February 2009
Last updated: October 24, 2008

Page last updated: November 03, 2008

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