Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy

Phase 4

Terminated

• Conditions: Pain, Postoperative
• Interventions: Drug: Morphine, Parecoxib; Drug: Morphine, Placebo

• Registration Number: NCT00346268
• Lead Sponsor: Pfizer

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-06-28
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-29
• Study Start: 2006-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-09
• Results First Submitted: 2011-09-21
• Results First Submitted QC: 2011-09-21
• Last Update Submitted: 2011-09-21
• Results First Posted: 2011-10-28
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 105

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine plus Parecoxib	Morphine, Parecoxib	-
Morphine and Placebo	Morphine, Placebo	-

Primary Outcome Measures

Name	Time	Method
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery	24 hours post 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

Name	Time	Method
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery	48 hours post 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	baseline (end of surgery) to 48 hours post surgery	Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
Amount of Blood Loss	48 hours post surgery	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	48 hours post surgery
Pain Intensity Score	12, 24, 36, and 48 hours post surgery	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	24 and 48 hours post surgery	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	24 and 48 hours post surgery	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	24 and 48 hours post surgery	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Reutlingen, Germany