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Trial record 1 of 1 for:    NCT00551135
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Surgical Pain After Inguinal Hernia Repair (SPAIHR)

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ClinicalTrials.gov Identifier: NCT00551135
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : July 15, 2010
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE October 26, 2007
First Posted Date  ICMJE October 30, 2007
Results First Submitted Date  ICMJE June 8, 2010
Results First Posted Date  ICMJE July 15, 2010
Last Update Posted Date January 25, 2021
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2007)
The primary endpoint is the worst pain reported by subjects (question 1 of the Modified Brief Pain Inventory - short form) on the first day (approximately 24 hours) after the surgery is completed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2007)
  • The pain reported by the subjects at rest at the baseline visit after the first screening visit, on the day of surgery in the hospital and daily in the diary following discharge (preceding pain with movement) through Day 7 or Begin of Taper visit.
  • The pain reported by the subjects with movement at the baseline visit after first screening visit, on the day of surgery in the hospital and daily in the diary following discharge (preceding pain with movement) through Day 7 or Begin of Taper visit.
  • Subject Global Evaluation of Study Medication (GESM) on Day 2, 24 hours after surgery.
  • The time in hours after surgery to first rescue medication use after surgery.
  • The amount of opioids used during and following surgery. It will be evaluated at the time of discharge from the hospital, and by subject diary on Days 2 through 7 or Begin of Taper visit.
  • Number of Clinically Meaningful Events (CME's), including individual and composite scores using the Opioid Related Symptom Distress Scale (OR SDS) on the day of surgery, Day 2, Day 4 and Day 7 or Begin of Taper visit.
  • The amounts of non opioid rescue medication (naproxen) used by the subjects during the study, including anti emetic medications on the day of surgery and Days 2 through 7 or Begin of Taper visit.
  • Average pain measured daily in subject diaries (NRS - Average Pain) on the day of surgery and Days 2 through 7 or Begin of Taper visit.
  • Sleep interference post surgery measured in daily subject diaries (NRS Sleep) on Days 2, 4 and 7 or Begin of Taper visit.
  • Anxiety (VAS) at bedtime the night before surgery, on the day of surgery and on Days 2 through 7 or Begin of Taper visit after the surgery.
  • Health status using EuroQol (EQ 5D) Health State Profile and the twelve item version of the short form acute health form (SF 12v2) on the baseline visit after the first screening visit.
  • Physician contacts to be collected by anesthesiologist, surgeon, or site staff 24 and 72 hours post discharge using Physician Contact questions (PC).
  • Time from the end of surgery (last stitch) it takes, to reach a score of 9 on post anesthetic discharge score system total (PADS) after the surgery.
  • Time from end of surgery to PACU discharge.
  • Relationship between baseline and postoperative Pain Catastrophizing Scale (PCS) score and severity of acute pain and to response to therapy measured at the baseline visit, on the day of surgery and on Day 7 or the Beginning of Taper visit.
  • Incidence of chronic post operative pain at 1, 3, and 6 months following surgery and the characteristics of the pain in those subjects reporting it (mBPI sf, NPSI).
  • Safety endpoint: All serious adverse events (SAEs), all treatment emergent adverse events (AEs) from the screening visit until the last day on the study.
  • Safety endpoint: Pre specified adverse events of wound healing complications
  • Safety endpoint: Vital signs and clinical laboratory parameters at the screening visit and on Day 7 or the Begin of Taper visit
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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