Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of parecoxib with placebo on the incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement for relieving severity of postthoracotomy shoulder pain and adverse events associated with treatment.

Detailed Description
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The incidence of Post-operative Ipsilateral Shoulder Pain (PISP) varies from 21-97% after thoracic surgery, despite receiving effective thoracic epidural analgesia. This pain has been described as constant, aching in quality, unrelated to position change or respiration. Possible causes of shoulder pain includes injury of the phrenic nerve, the lateral decubitus position, transection of major bronchus or preexisting arthritis condition. The possibilities of prevention and management of PISP are taken into consideration. Thoracic epidural block will be performed in all patients before general anesthesia.

Official Title
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Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.

Conditions
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Shoulder Pain, Post-operative Pain

Intervention / Treatment
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* Drug: Parecoxib
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology (ASA) physical status I-III Undergoing pulmonary resection by open thoracotomy Exclusion Criteria: Unable to understand numeric rating scale despite preoperative coaching Preexisting shoulder pain at the same operative side Having contraindication for thoracic epidural analgesia History of previous myocardial ischemia or cerebrovascular accident Allergic to NSAIDS, sulfonamides or parecoxib Hepatic or renal impairment History of current gastrointestinal symptoms Fluid retention or congestive heart failure Pregnancy

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parecoxib<br>Parecoxib 2 ml intravenous | Drug: Parecoxib<br>* Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.<br>* Other names: Dynastat;|
| Placebo Comparator: Control<br>0.9% sodium chloride 2 ml intravenous | Other: Control<br>* NSS 2 ml intravenous before surgery and every 12 hours for two days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement |  | at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare an amount of morphine consumption |  | at 2,6 ,12,24,48,72 and 96 hours after the operation | 
| adverse effect related to parecoxib |  | during 96 hours |