Clinical trial NCT00346268: Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-29
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
timeFrame: 24 hours post surgery
Secondary outcomes:
measure: Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
timeFrame: 48 hours post surgery
measure: Time to Last Administration of Morphine
timeFrame: baseline (end of surgery) to 48 hours post surgery
measure: Amount of Blood Loss
timeFrame: 48 hours post surgery
measure: Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
timeFrame: 48 hours post surgery
measure: Pain Intensity Score
timeFrame: 12, 24, 36, and 48 hours post surgery
measure: Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
timeFrame: 24 and 48 hours post surgery
measure: Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
timeFrame: 24 and 48 hours post surgery
measure: Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
timeFrame: 24 and 48 hours post surgery
Other outcomes:
measure: Number of Participants With Rating of Global Evaluation of Study Medication
timeFrame: 48 hours post surgery
measure: Number of Participants With Health Care Resource Utilization (HCRU)
timeFrame: 24 and 48 hours post surgery
measure: Overall Analgesic Benefit Score (OABS)
timeFrame: 24 and 48 hours post surgery
measure: Hemoglobin Concentration
timeFrame: 24 hours post surgery
measure: Total Amount of Postoperative Drainage Fluid
timeFrame: 24 hours post surgery
Locations:
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Reutlingen
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.