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

Condition(s) targeted: Pain, Postoperative

Intervention: Morphine, placebo (Drug); Morphine, parecoxib (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The main outcome is the evaluation of the total cumulative amount of morphine administered (PCA and bolus) in the 24 hours after the end of surgery (i.e. application of the last surgical stitch after radical prostatectomy).

Secondary outcome:

Time of last administration of morphine (PCA and/or bolus dose).

The total cumulative amount of morphine administered (Patient Controlled Analgesia [PCA] and bolus) in the 48h after the end of surgery.

Modified Brief Pain Inventory-Short Form (mBPI-sf) after 24 and 48 hours.

Health Care Resource Utilization (HCRU) 24 and 48 hours after surgery.

Assessment of adverse events 12, 24, 36, 48 hours after skin closure and at the Follow-up visit.

Time specific pain intensity (categorical scales) at rest and at movement 12, 24, 36, and 48 hours after end of surgery (defined as application of the last surgical stitch)

Patient's global evaluation of study medication 48 hours after skin closure.

Opiate Related Symptom Distress Scale Questionnaire (OR-SDS) after 24 and 48 hours.

Patient global assessment of analgesic experience (Overall analgesic benefit score, OABS) 24 and 48 hours after skin closure.

Blood loss, defined as: ([Hb g/dL]pra + RBCUduring48 ) - [Hb g/dL]@48, where ([Hb g/dL]pra is the blood hemoglobin concentration preoperatively, [Hb g/dL]@48 is the blood hemoglobin concentration 48h after skin closure, and RBCUduring48 is the number

of red blood cell units (RBCU) substituted during and after prostatectomy until 48 h after skin closure.

Hemoglobin concentration

total amount of postoperative drainage fluid will be assessed 24 h after skin closure.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Reutlingen 72764, Germany; Recruiting

Pfizer Investigational Site, Essen 45136, Germany; Recruiting

Pfizer Investigational Site, Koeln-Lindenthal 50925, Germany; Terminated

Pfizer Investigational Site, Heidelberg 69121, Germany; Terminated

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

Starting date: December 2006
Ending date: June 2011
Last updated: September 30, 2009