A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.

Detailed Description
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This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.

Official Title
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A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery

Conditions
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Pain

Intervention / Treatment
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* Drug: Parecoxib/Valdecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery American Society of Anaesthesiologists (ASA) Physical Status I-III Exclusion Criteria: Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: Parecoxib/Valdecoxib<br>* A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3<br>|
| Placebo Comparator: Group 2<br> | Drug: Placebo<br>* A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group. |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of unplanned hospital admissions on Day 4. |  | 4 days | 
| Health Outcomes Recovery Questionnaire on Days 2, 3, and 4. |  | 4 days | 
| Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4. |  | 4 days | 
| Length of stay on Day 1. |  | 1 day | 
| Patient Satisfaction Questionnaire on Days 1 and 4. |  | 4 days | 
| Quality of Recovery Score on Days 1, 2, and 3. |  | 3 days | 
| Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4. |  | 4 days | 
| Modified Brief Pain Inventory on Days 2, 3, and 4. |  | 4 days | 
| Readiness for discharge on Day 1. |  | 1 day |