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Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postoperative Pain
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
25-70 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 total abdominal hysterectomy using a transverse
incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may,
however, be cervix-sparing.

- The subject is expected to remain at the hospital (or intermediate care facility) for
a minimum of 2 days following surgery.

- The subject's preoperative health is graded as the American Society of
Anesthesiologist P1 to P2.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)

- Subjects having additional procedures (such as those involving the bladder) at the
same time as the total abdominal hysterectomy

- The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical
pain control

- Subjects who have been using any opioid medications 2 weeks or more continuously
within 3 months prior to the screening visit.

- The subject has taken any NSAID or any analgesic other than acetaminophen within 3
days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics,
except as specified in the protocol, during the study. (Subjects taking day of aspirin at a stable dose for at least 30 days before the first dose of study
medication will be allowed to continue their aspirin regimen for the duration of the
study).

NCT00468845
Pfizer
Completed
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

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