Surgical Pain After Inguinal Hernia Repair (SPAIHR)

NCT00551135

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235, United States
Contact
1-800-718-1021

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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.

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Postoperative Pain, Inguinal HerniaSurgical Pain After Inguinal Hernia Repair (SPAIHR)
NCT00551135
  1. Birmingham, Alabama
  2. Glendale, California
  3. Laguna Hills, California
  4. Pasadena, California
  5. Lake Worth, Florida
  6. Pensacola, Florida
  7. Rochester, Minnesota
  8. Rochester, New York
  9. Stony Brook, New York
  10. Durham, North Carolina
  11. Columbus, Ohio
  12. Pittsburgh, Pennsylvania
  13. Hermitage, Tennessee
  14. Hermitage, Tennessee
  15. Knoxville, Tennessee
  16. Knoxville, Tennessee
  17. Nashville, Tennessee
  18. Dallas, Texas
  19. Houston, Texas
  20. Houston, Texas
  21. Houston, Texas
  22. Houston, Texas
  23. Humble, Texas
  24. Kingwood, Texas
  25. Randwick, New South Wales
  26. London, Ontario
  27. London, Ontario
  28. Charlottetown, Prince Edward Island
  29. Quebec,
  30. Baroda, Gujarat
  31. Pune, Maharashtra
  32. Madurai, Tamil Nadu
  33. Delhi,
  34. Alcorcon, Madrid
  35. Barcelona,
  36. Madrid,
  37. Madrid,
  38. Gavle,
  39. Landskrona,
  40. Mora,
  41. Orebro,
  42. Skelleftea,
Male
17 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Surgical Pain After Inguinal Hernia Repair (SPAIHR)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Hernia, Inguinal
Intervention  ICMJE
  • Drug: Pregabalin
    150 mg BID
  • Drug: placebo
    Placebo
  • Drug: Pregabalin
    75 mg BID
  • Drug: Pregabalin
    25 mg BID
Study Arms  ICMJE
  • Experimental: 3
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 4
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: Pregabalin
  • Experimental: 1
    Intervention: Drug: Pregabalin
Publications * Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2010)
425
Original Enrollment  ICMJE
 (submitted: October 26, 2007)
400
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 17 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   India,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00551135
Other Study ID Numbers  ICMJE A0081171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP