Surgical Pain After Inguinal Hernia Repair (SPAIHR)

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative, Hernia, Inguinal

In brief

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.

Key facts

Study ID: NCT00551135
Run by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
People needed: 425
Starts: 2008-01-01
Expected to finish: 2009-09-01
Last updated by the study team: 2021-01-25

Who can join

Age: 17 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Pfizer Investigational Site — Birmingham, Alabama, United States
Pfizer Investigational Site — Glendale, California, United States
Pfizer Investigational Site — Laguna Hills, California, United States
Pfizer Investigational Site — Pasadena, California, United States
Pfizer Investigational Site — Lake Worth, Florida, United States
Pfizer Investigational Site — Pensacola, Florida, United States
Pfizer Investigational Site — Rochester, Minnesota, United States
Pfizer Investigational Site — Rochester, New York, United States
Pfizer Investigational Site — Stony Brook, New York, United States
Pfizer Investigational Site — Durham, North Carolina, United States
Pfizer Investigational Site — Columbus, Ohio, United States
Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site — Hermitage, Tennessee, United States
Pfizer Investigational Site — Hermitage, Tennessee, United States
Pfizer Investigational Site — Knoxville, Tennessee, United States
Pfizer Investigational Site — Knoxville, Tennessee, United States
Pfizer Investigational Site — Nashville, Tennessee, United States
Pfizer Investigational Site — Dallas, Texas, United States
Pfizer Investigational Site — Houston, Texas, United States
Pfizer Investigational Site — Houston, Texas, United States
Pfizer Investigational Site — Houston, Texas, United States
Pfizer Investigational Site — Houston, Texas, United States
Pfizer Investigational Site — Humble, Texas, United States
Pfizer Investigational Site — Kingwood, Texas, United States
Pfizer Investigational Site — Randwick, New South Wales, Australia

Full record on ClinicalTrials.gov

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