Clinical trial NCT00442546: Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Official title: A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Postoperative Pain
Keywords: opioid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.


Eligibility criteria: Inclusion Criteria:

* Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
* Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
* The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3

Exclusion Criteria:

* Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
* Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
* Subjects with fibromyalgia and or other chronic pain syndromes

Primary outcomes:
measure: Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Cumulative Total Amount of Opioids Used During the Entire Hospital Stay
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours
measure: Opioids Used Post Discharge
timeFrame: Week 2, Week 4, Week 6/Early Termination (ET)
measure: Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)
timeFrame: 24 hours, 48 hours, 72 hours
measure: Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]
timeFrame: Week 2, Week 4, Week 6/ET
measure: Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups
timeFrame: Week 2, Week 4, Week 6/ET
measure: Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group
timeFrame: Week 2, Week 4, Week 6/ET
measure: Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4
timeFrame: Week 4
measure: Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4
timeFrame: Week 4
measure: Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET
timeFrame: Week 6/ET
measure: Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET
timeFrame: Week 6/ET
measure: The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
measure: The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
measure: The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
measure: The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
measure: Total Clinically Meaningful Event (CME) Score
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET
measure: Pain Interference Index Score as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With Relations With People as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With General Activity as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With Mood as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With Walking Ability as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With Normal Work as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Pain Interference With Sleep as Measured by the m-BPI-sf
timeFrame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
measure: Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)
timeFrame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
measure: Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS
timeFrame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
measure: Current Pain During the Hospital Stay Assessed by the Pain NRS
timeFrame: 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay
measure: Pain-Related Sleep Interference Post Surgery
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET
measure: Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery
timeFrame: Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery
measure: Timed Up-and-Go (TUG)
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET
measure: Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
measure: ROM Assessment of the Passive Flexion of the Surgical Knee
timeFrame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
measure: Time From End of Surgery to Meet Hospital Discharge Criteria
timeFrame: time from end of surgery up to 192 hours post surgery
measure: Time From End of Surgery to Actual Discharge
timeFrame: time from end of surgery up to 192 hours post surgery
measure: Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)
timeFrame: Discharge, Week 2, Week 4, Week 6/ET
measure: Satisfaction With Medication Characteristics Measured by the PTSS
timeFrame: Discharge, Week 2, Week 4, Week 6/ET
measure: Satisfaction With Medication Efficacy Measured by the PTSS
timeFrame: Discharge, Week 2, Week 4, Week 6/ET
measure: Overall Satisfaction Measured by the PTSS
timeFrame: Discharge, Week 2, Week 4, and Week 6/ET
measure: Overall Pain Relief Measured by the PTSS
timeFrame: Discharge, Week 2, Week 4, and Week 6/ET
measure: Number of Subjects With Global Evaluation of Study Medication Scores
timeFrame: Discharge, Week 2, Week 4, and Week 6/ET
measure: Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)
timeFrame: Month 3, Month 6 (phone call)
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Month 3, Month 6 (phone call)
Other outcomes:
Locations:
city: Northport
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Galesburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Iberia
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Egg Harbor Township
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Pomona
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Upper Arlington
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: King Of Prussia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
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.