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Surgical Pain After Inguinal Hernia Repair (SPAIHR)

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NCT00551135

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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.
Show details

- 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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Surgical Pain After Inguinal Hernia Repair (SPAIHR)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Pain, Postoperative
  • Hernia, Inguinal
  • Drug: Pregabalin
    150 mg BID
  • Drug: placebo
    Placebo
  • Drug: Pregabalin
    75 mg BID
  • Drug: Pregabalin
    25 mg BID
  • Experimental: 3
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 4
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: Pregabalin
  • Experimental: 1
    Intervention: Drug: Pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
September 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
17 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   India,   Spain,   Sweden,   United States
 
 
NCT00551135
A0081171
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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