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Surgical Pain After Inguinal Hernia Repair (SPAIHR)

Last updated on February 22, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postoperative Pain, Inguinal Hernia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
17-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00551135
Pfizer
Completed
Surgical Pain After Inguinal Hernia Repair (SPAIHR)

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now