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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00551135




Registration number
NCT00551135
Ethics application status
Date submitted
26/10/2007
Date registered
30/10/2007
Date last updated
25/01/2021

Titles & IDs
Public title
Surgical Pain After Inguinal Hernia Repair (SPAIHR)
Scientific 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
Secondary ID [1] 0 0
A0081171
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Postoperative 0 0
Hernia, Inguinal 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pregabalin
Treatment: Drugs - placebo
Treatment: Drugs - Pregabalin
Treatment: Drugs - Pregabalin

Experimental: 3 -

Placebo comparator: 4 -

Experimental: 2 -

Experimental: 1 -


Treatment: Drugs: Pregabalin
150 mg BID

Treatment: Drugs: placebo
Placebo

Treatment: Drugs: Pregabalin
75 mg BID

Treatment: Drugs: Pregabalin
25 mg BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery
Timepoint [1] 0 0
24 hours post surgery
Secondary outcome [1] 0 0
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting
Timepoint [1] 0 0
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])
Secondary outcome [2] 0 0
Numeric Rating Scale (NRS): Current Pain With Movement - Walking
Timepoint [2] 0 0
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])
Secondary outcome [3] 0 0
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing
Timepoint [3] 0 0
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])
Secondary outcome [4] 0 0
Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing
Timepoint [4] 0 0
1 hour through 48 hours post surgery
Secondary outcome [5] 0 0
Numerical Rating Scale (NRS): Current Pain at Rest
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)
Timepoint [6] 0 0
1 through 48 hours post surgery (PS)
Secondary outcome [7] 0 0
Numeric Rating Scale (NRS): Average Pain
Timepoint [7] 0 0
2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS
Secondary outcome [8] 0 0
Time From End of Surgery to First Rescue Medication
Timepoint [8] 0 0
Day 1 through Day 7 post surgery
Secondary outcome [9] 0 0
Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)
Timepoint [10] 0 0
Day 1
Secondary outcome [11] 0 0
Daily Sleep Interference Rating Scale (DSIRS) Score
Timepoint [11] 0 0
Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)
Secondary outcome [12] 0 0
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery
Timepoint [12] 0 0
24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS
Secondary outcome [13] 0 0
Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study
Timepoint [13] 0 0
End of Surgery through Day 7 post surgery
Secondary outcome [14] 0 0
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)
Timepoint [14] 0 0
3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
Secondary outcome [15] 0 0
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)
Timepoint [15] 0 0
3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
Secondary outcome [16] 0 0
Subject Global Evaluation of Study Medication (GESM)
Timepoint [16] 0 0
24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
Secondary outcome [17] 0 0
Participants With Wound Healing Complications
Timepoint [17] 0 0
Day 7 post surgery (PS) and up to 30 days PS
Secondary outcome [18] 0 0
Participants With Physician Contacts Post-discharge
Timepoint [18] 0 0
24 and 72 hours (h) post surgery (PS)
Secondary outcome [19] 0 0
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score
Timepoint [19] 0 0
Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS
Secondary outcome [20] 0 0
Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score
Timepoint [20] 0 0
Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
Secondary outcome [21] 0 0
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales
Timepoint [21] 0 0
3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
Secondary outcome [22] 0 0
Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy
Timepoint [22] 0 0
Baseline and Days 1 and 7 post surgery (PS)
Secondary outcome [23] 0 0
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)
Timepoint [23] 0 0
Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
Secondary outcome [24] 0 0
Participants With Chronic Postoperative Pain
Timepoint [24] 0 0
1, 3, and 6 months (mo) post surgery (PS)
Secondary outcome [25] 0 0
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Timepoint [25] 0 0
1, 3, and 6 months (mo) post surgery (PS)
Secondary outcome [26] 0 0
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)
Timepoint [26] 0 0
1, 3, and 6 months (mo) post surgery (PS)

Eligibility
Key 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.
Minimum age
17 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
425
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Prince Edward Island
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
India
State/province [14] 0 0
Gujarat
Country [15] 0 0
India
State/province [15] 0 0
Maharashtra
Country [16] 0 0
India
State/province [16] 0 0
Tamil Nadu
Country [17] 0 0
India
State/province [17] 0 0
Delhi
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Sweden
State/province [20] 0 0
Gavle
Country [21] 0 0
Sweden
State/province [21] 0 0
Landskrona
Country [22] 0 0
Sweden
State/province [22] 0 0
Mora
Country [23] 0 0
Sweden
State/province [23] 0 0
Orebro
Country [24] 0 0
Sweden
State/province [24] 0 0
Skelleftea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00551135