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Trial record 1 of 3 for:    PFIZER HERNIA
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Surgical Pain After Inguinal Hernia Repair (SPAIHR)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00551135
First received: October 26, 2007
Last updated: June 8, 2010
Last verified: June 2010
  Purpose
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.

Condition Intervention Phase
Pain, Postoperative Hernia, Inguinal Drug: Pregabalin Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery [ Time Frame: 24 hours post surgery ]
    m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).


Secondary Outcome Measures:
  • Numeric Rating Scale (NRS): Current Pain With Movement - Sitting [ Time Frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).

  • Numeric Rating Scale (NRS): Current Pain With Movement - Walking [ Time Frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).

  • Numeric Rating Scale (NRS): Current Pain With Movement - Coughing [ Time Frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)

  • Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing [ Time Frame: 1 hour through 48 hours post surgery ]
    NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).

  • Numerical Rating Scale (NRS): Current Pain at Rest [ Time Frame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS ]
    NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).

  • Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) [ Time Frame: 1 through 48 hours post surgery (PS) ]
    NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).

  • Numeric Rating Scale (NRS): Average Pain [ Time Frame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS ]
    NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).

  • Time From End of Surgery to First Rescue Medication [ Time Frame: Day 1 through Day 7 post surgery ]
    Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.

  • Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS) [ Time Frame: Day 1 ]
    PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.

  • Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU) [ Time Frame: Day 1 ]
  • Daily Sleep Interference Rating Scale (DSIRS) Score [ Time Frame: Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS) ]
    DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.

  • Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery [ Time Frame: 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS ]
    Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.

  • Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study [ Time Frame: End of Surgery through Day 7 post surgery ]
    Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.

  • Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) [ Time Frame: 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]).

  • Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) [ Time Frame: 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).

  • Subject Global Evaluation of Study Medication (GESM) [ Time Frame: 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.

  • Participants With Wound Healing Complications [ Time Frame: Day 7 post surgery (PS) and up to 30 days PS ]
    Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.

  • Participants With Physician Contacts Post-discharge [ Time Frame: 24 and 72 hours (h) post surgery (PS) ]
    Number of participants who answered "yes" to the Post-Surgery Contact question: "From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"

  • Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score [ Time Frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS ]
    Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.

  • Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score [ Time Frame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination]) ]
    EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.

  • Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales [ Time Frame: 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination]) ]
    The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.

  • Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy [ Time Frame: Baseline and Days 1 and 7 post surgery (PS) ]
    The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.

  • Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) [ Time Frame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination]) ]
    PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.

  • Participants With Chronic Postoperative Pain [ Time Frame: 1, 3, and 6 months (mo) post surgery (PS) ]
    Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: "In the last 24 hours, have you had pain in the area affected by your surgery?")

  • Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) [ Time Frame: 1, 3, and 6 months (mo) post surgery (PS) ]
    m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).

  • Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: 1, 3, and 6 months (mo) post surgery (PS) ]
    NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.


Enrollment: 425
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 Drug: Pregabalin
150 mg BID
Placebo Comparator: 4 Drug: placebo
Placebo
Experimental: 2 Drug: Pregabalin
75 mg BID
Experimental: 1 Drug: Pregabalin
25 mg BID

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551135

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Pfizer Investigational Site
Laguna Hills, California, United States, 92653
Pfizer Investigational Site
Pasadena, California, United States, 91105
United States, Florida
Pfizer Investigational Site
Lake Worth, Florida, United States, 33462
Pfizer Investigational Site
Pensacola, Florida, United States, 32504
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14642
Pfizer Investigational Site
Stony Brook, New York, United States, 11794-8480
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Pfizer Investigational Site
Hermitage, Tennessee, United States, 37075
Pfizer Investigational Site
Hermitage, Tennessee, United States, 37076
Pfizer Investigational Site
Knoxville, Tennessee, United States, 27920
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75390-7208
Pfizer Investigational Site
Houston, Texas, United States, 77024
Pfizer Investigational Site
Houston, Texas, United States, 77054
Pfizer Investigational Site
Houston, Texas, United States, 77091
Pfizer Investigational Site
Houston, Texas, United States, 77098
Pfizer Investigational Site
Humble, Texas, United States, 77338
Pfizer Investigational Site
Kingwood, Texas, United States, 77339
Australia, New South Wales
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4V2
Pfizer Investigational Site
London, Ontario, Canada, N6A 5A5
Canada, Prince Edward Island
Pfizer Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4G2
India
Pfizer Investigational Site
Baroda, Gujarat, India, 390001
Pfizer Investigational Site
Pune, Maharashtra, India, 411011
Pfizer Investigational Site
Madurai, Tamil Nadu, India, 625 107
Pfizer Investigational Site
Delhi, India, 110 095
Spain
Pfizer Investigational Site
Alcorcon, Madrid, Spain, 28922
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Madrid, Spain, 28006
Pfizer Investigational Site
Madrid, Spain, 28031
Sweden
Pfizer Investigational Site
Gavle, Sweden, 801-87
Pfizer Investigational Site
Landskrona, Sweden, 261 24
Pfizer Investigational Site
Mora, Sweden, SE-792 85
Pfizer Investigational Site
Orebro, Sweden, 701 85
Pfizer Investigational Site
Skelleftea, Sweden, 931 86
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00551135     History of Changes
Other Study ID Numbers: A0081171
Study First Received: October 26, 2007
Results First Received: June 8, 2010
Last Updated: June 8, 2010

Keywords provided by Pfizer:
postoperative pain chronic pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pain, Postoperative
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 26, 2017