Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

Phase 2

Completed

• Conditions: Post-operative Pain; Shoulder Pain
• Interventions: Other: Control; Drug: Parecoxib

• Registration Number: NCT01288924
• Lead Sponsor: Chiang Mai University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-03
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	0.9% sodium chloride 2 ml intravenous
Parecoxib	Parecoxib	Parecoxib 2 ml intravenous

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
adverse effect related to parecoxib	during 96 hours
compare an amount of morphine consumption	at 2,6 ,12,24,48,72 and 96 hours after the operation

Trial Locations

Locations (2)

Department of Anesthesiology, Faculty of Medicine; 🇹🇭 Maung, Chiang Mai, Thailand

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University; 🇹🇭 Maung, Chiang Mai, Thailand