Surgical Pain After Inguinal Hernia Repair (SPAIHR)
United States, Australia, Canada425 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range
17 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 indicat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery
Timeframe: 24 hours post surgery
Trial details
NCT IDNCT00551135
SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.