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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Morphine, Parecoxib; Drug: Morphine, Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45136
    • Pfizer Investigational Site
  • Heidelberg, Germany, 69121
    • Pfizer Investigational Site
  • Koeln, Germany, 50924
    • Pfizer Investigational Site
  • Reutlingen, Germany, 72764
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morphine plus Parecoxib	Drug: Morphine, Parecoxib; 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.
Active Comparator: Morphine and Placebo	Drug: Morphine, Placebo; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours post surgery
Time to Last Administration of Morphine	Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).	baseline (end of surgery) to 48 hours post surgery
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.	48 hours post surgery
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units		48 hours post surgery
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.	12, 24, 36, and 48 hours post surgery
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).	24 and 48 hours post surgery
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.	24 and 48 hours post surgery
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.	24 and 48 hours post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Rating of Global Evaluation of Study Medication	Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.	48 hours post surgery
Number of Participants With Health Care Resource Utilization (HCRU)	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".	24 and 48 hours post surgery
Overall Analgesic Benefit Score (OABS)	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.	24 and 48 hours post surgery
Hemoglobin Concentration		24 hours post surgery
Total Amount of Postoperative Drainage Fluid	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.	24 hours post surgery

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 28, 2006
• First Submitted That Met QC Criteria: June 28, 2006
• First Posted (Estimate): June 29, 2006

Study Record Updates

• Last Update Posted (Estimate): October 28, 2011
• Last Update Submitted That Met QC Criteria: September 21, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Cyclooxygenase 2 Inhibitors; Morphine; Parecoxib
• Other Study ID Numbers: A3481066