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

Phase 4TerminatedNCT00346268

Pfizer105 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Pain, Postoperative

Interventions

Morphine, ParecoxibDRUG

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, PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Pfizer Investigational Site

Cologne, Germany

Pfizer Investigational Site

Essen, Germany

Pfizer Investigational Site

Heidelberg, Germany

Pfizer Investigational Site

Reutlingen, Germany

Outcomes

Primary Outcomes

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.

Time frame: 24 hours post surgery

Secondary Outcomes

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 frame: 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).

Time frame: 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.

Time frame: 48 hours post surgery

Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units

Time frame: 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.

Data from ClinicalTrials.gov

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