Clinical trial NCT00551135: Surgical Pain After Inguinal Hernia Repair (SPAIHR)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Hernia, Inguinal
Keywords: postoperative pain chronic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 425
Sex: MALE
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery
timeFrame: 24 hours post surgery
Secondary outcomes:
measure: Numeric Rating Scale (NRS): Current Pain With Movement - Sitting
timeFrame: 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])
measure: Numeric Rating Scale (NRS): Current Pain With Movement - Walking
timeFrame: 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])
measure: Numeric Rating Scale (NRS): Current Pain With Movement - Coughing
timeFrame: 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])
measure: Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing
timeFrame: 1 hour through 48 hours post surgery
measure: Numerical Rating Scale (NRS): Current Pain at Rest
timeFrame: 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
measure: Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)
timeFrame: 1 through 48 hours post surgery (PS)
measure: Numeric Rating Scale (NRS): Average Pain
timeFrame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS
measure: Time From End of Surgery to First Rescue Medication
timeFrame: Day 1 through Day 7 post surgery
measure: Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)
timeFrame: Day 1
measure: Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)
timeFrame: Day 1
measure: Daily Sleep Interference Rating Scale (DSIRS) Score
timeFrame: Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)
measure: Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery
timeFrame: 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS
measure: Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study
timeFrame: End of Surgery through Day 7 post surgery
measure: Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)
timeFrame: 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
measure: Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)
timeFrame: 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
measure: Subject Global Evaluation of Study Medication (GESM)
timeFrame: 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
measure: Participants With Wound Healing Complications
timeFrame: Day 7 post surgery (PS) and up to 30 days PS
measure: Participants With Physician Contacts Post-discharge
timeFrame: 24 and 72 hours (h) post surgery (PS)
measure: Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score
timeFrame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS
measure: Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score
timeFrame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
measure: Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales
timeFrame: 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
measure: Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy
timeFrame: Baseline and Days 1 and 7 post surgery (PS)
measure: 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)
timeFrame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
measure: Participants With Chronic Postoperative Pain
timeFrame: 1, 3, and 6 months (mo) post surgery (PS)
measure: Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
timeFrame: 1, 3, and 6 months (mo) post surgery (PS)
measure: Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: 1, 3, and 6 months (mo) post surgery (PS)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Humble
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Kingwood
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Baroda
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Madurai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Delhi
country: India
facility: Pfizer Investigational Site
city: Alcorcon
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Gavle
country: Sweden
facility: Pfizer Investigational Site
city: Landskrona
country: Sweden
facility: Pfizer Investigational Site
city: Mora
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Skelleftea
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.