Back to resultsMorphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy (PROSTATECTOMY)
Primary Purpose
Pain, Postoperative
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Morphine, Parecoxib
Morphine, Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria: The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator. The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia. Exclusion Criteria: The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Morphine plus Parecoxib
Morphine and Placebo
Arm Description
Outcomes
Primary Outcome Measures
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
Secondary Outcome Measures
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.
Time to Last Administration of Morphine
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
Amount of Blood Loss
Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Pain Intensity Score
Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).
Movement defined as sitting up from a lying into a sitting position in bed.
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00346268
Brief Title
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
Acronym
PROSTATECTOMY
Official Title
Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.
Detailed Description
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine plus Parecoxib
Arm Type
Active Comparator
Arm Title
Morphine and Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Morphine, Parecoxib
Intervention Description
Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
Intervention Type
Drug
Intervention Name(s)
Morphine, Placebo
Intervention Description
Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
Primary Outcome Measure Information:
Title
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Description
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
Time Frame
24 hours post surgery
Secondary Outcome Measure Information:
Title
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Description
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.
Time Frame
48 hours post surgery
Title
Time to Last Administration of Morphine
Description
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
Time Frame
baseline (end of surgery) to 48 hours post surgery
Title
Amount of Blood Loss
Description
Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.
Time Frame
48 hours post surgery
Title
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Time Frame
48 hours post surgery
Title
Pain Intensity Score
Description
Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).
Movement defined as sitting up from a lying into a sitting position in bed.
Time Frame
12, 24, 36, and 48 hours post surgery
Title
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
Description
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).
Time Frame
24 and 48 hours post surgery
Title
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
Description
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.
Time Frame
24 and 48 hours post surgery
Title
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Description
Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.
Time Frame
24 and 48 hours post surgery
Other Pre-specified Outcome Measures:
Title
Number of Participants With Rating of Global Evaluation of Study Medication
Description
Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.
Time Frame
48 hours post surgery
Title
Number of Participants With Health Care Resource Utilization (HCRU)
Description
Supervising physician or nurse answered question in the presence of participant, "In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist".
Time Frame
24 and 48 hours post surgery
Title
Overall Analgesic Benefit Score (OABS)
Description
Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.
Time Frame
24 and 48 hours post surgery
Title
Hemoglobin Concentration
Time Frame
24 hours post surgery
Title
Total Amount of Postoperative Drainage Fluid
Description
After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.
Time Frame
24 hours post surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
Exclusion Criteria:
The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
Pfizer Investigational Site
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Pfizer Investigational Site
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25767411
Citation
Dirkmann D, Groeben H, Farhan H, Stahl DL, Eikermann M. Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial. BMC Anesthesiol. 2015 Mar 9;15:31. doi: 10.1186/s12871-015-0015-y. eCollection 2015.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3481066&StudyName=Morphine-Sparing%20Efficacy%20Of%20Parecoxib%20In%20Pain%20Treatment%20After%20Radical%20Prostatectomy
Description
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Learn more about this trial
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
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