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

Pain, Postoperative Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00346268
• Other study ID #: A3481066
• Status: Terminated
• Phase: Phase 4
• First received: June 28, 2006
• Last updated: September 21, 2011
• Start date: December 2006
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Heidelberg
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Reutlingen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units		48 hours post surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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