Clinical trial NCT00468845: Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Official title: A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: pain after hysterectomy
amount of opioids used
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 501
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.


Eligibility criteria: Inclusion Criteria:

* The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
* The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
* The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.

Exclusion Criteria:

* Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
* Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
* The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
* Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
* The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking \<325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).

Primary outcomes:
measure: Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
timeFrame: Day 2 (24 hours post surgery [PS])
Secondary outcomes:
measure: Current Pain - Pain With Movement Caused by Sitting
timeFrame: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS
measure: Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test
timeFrame: Day 1, up to 7 days PS, 2 and 4 weeks PS
measure: Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting
timeFrame: 48 +/- 4 hours PS
measure: Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test
timeFrame: 48 +/- 4 hours PS
measure: Current Pain at Rest
timeFrame: 8, 16, 24, 32, 40, 48 hours PS
measure: Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay
timeFrame: 48 +/- 4 hours PS
measure: Total Cumulative Dose of Opioids Following Surgery
timeFrame: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS)
measure: Integrated Analgesic Score
timeFrame: 0-24, 24-48, 48-72 hours PS
measure: Non-opioid Rescue Medication - Paracetamol
timeFrame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,
measure: Anxiety Before and After Surgery
timeFrame: Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)
measure: Non-opioid Rescue Medication - Ibuprofen
timeFrame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS
measure: Percent Change From Baseline in Peak Expiratory Flow
timeFrame: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)
measure: Timed Up-and-Go (TUG)
timeFrame: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)
measure: Average Daily Pain
timeFrame: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS
measure: Worst Daily Pain
timeFrame: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
measure: Sleep Interference
timeFrame: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS
measure: Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
timeFrame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
measure: Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
timeFrame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
measure: Participant Satisfaction With Study Medication - Surgery Day
timeFrame: Day 1
measure: Participant Satisfaction With Study Medication - Day 1 PS
timeFrame: Day 1 PS
measure: Participant Satisfaction With Study Medication - Day 2 PS
timeFrame: Day 2 PS
measure: Participant Satisfaction With Study Medication - Day 3 PS
timeFrame: Day 3 PS
measure: Participant Satisfaction With Study Medication - Day 4 PS
timeFrame: Day 4 PS
measure: Participant Satisfaction With Study Medication - Day 5 PS
timeFrame: Day 5 PS
measure: Participant Satisfaction With Study Medication - Discharge
timeFrame: Discharge (day 3 up to day 7 PS)
measure: Participant Satisfaction With Study Medication - Day 7 PS
timeFrame: Day 7 PS
measure: Participant Satisfaction With Study Medication - Day 14 PS
timeFrame: Day 14 PS
measure: Participant Satisfaction With Study Medication - Day 28 PS
timeFrame: Day 28 PS
measure: Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
timeFrame: Discharge (day 3 up to day 7 PS), Day 28 PS
measure: Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
timeFrame: Discharge (day 3 up to day 7 PS), Day 28 PS
measure: Quality of Life Using EuroQol (EQ-5D) Health State Profile
timeFrame: Discharge (day 3 up to day 7 PS) and day 28 PS
measure: Time to Meet Hospital Discharge Criteria
timeFrame: Day 1 up to Day 7 PS
measure: Time to Actual Discharge
timeFrame: Day 1 up to Day 7 PS
measure: Incidence of Chronic Post-operative Pain
timeFrame: 3 and 6 Months PS
measure: Total Clinically Meaningful Event (CME) Score
timeFrame: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
Other outcomes:
measure: Percentage of Participants With Wound Healing Complications - Discharge
timeFrame: Discharge (day 3 up to day 7 PS)
measure: Percentage of Participants With Wound Healing Complications - Day 7 PS
timeFrame: Day 7 PS
measure: Percentage of Participants With Wound Healing Complications - Day 14 PS
timeFrame: Day 14 PS
measure: Percentage of Participants With Wound Healing Complications - Day 28 PS
timeFrame: Day 28 PS
measure: Percentage of Participants With Wound Healing Complications - End of Treatment
timeFrame: Day 1 up to Day 28 PS
measure: Incision Length Correlated With Worst Pain
timeFrame: Day 1
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Discharge (day 3 up to day 7 PS)
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
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: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Newcastle
country: South Africa
facility: Pfizer Investigational Site
state: KwaZulu Natal
city: Ladysmith
country: South Africa
facility: Pfizer Investigational Site
state: KZN
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
city: Cadiz
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Bangkoknoi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Muang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
city: Muang
country: Thailand
facility: Pfizer Investigational Site
state: Khon Kaen
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
state: Leicestershire
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Livingstone
country: United Kingdom
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.