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Surgical Pain After Inguinal Hernia Repair (SPAIHR)

CompletedPhase 3NCT00551135
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study 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
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Organization
Pfizer
Start date
2008-01
Primary completion
2009-06
Sex
Male
Age range
from 17 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Australia, Canada, India, Spain, Sweden, United States
Total sites listed
42

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Canadian sites (4)

FacilityCityProvince
Pfizer Investigational SiteLondonOntario
Pfizer Investigational SiteLondonOntario
Pfizer Investigational SiteCharlottetownPrince Edward Island
Pfizer Investigational SiteQuébecQuebec
Canadian sites for NCT00551135LondonCharlottetownQuébec
Canadian sites for NCT00551135. 3 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00551135