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Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

NCT ID: NCT01288924

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-01-31

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.

Conditions

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Shoulder Pain Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Parecoxib

Parecoxib 2 ml intravenous

Group Type ACTIVE_COMPARATOR

Parecoxib

Intervention Type DRUG

Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.

Control

0.9% sodium chloride 2 ml intravenous

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

NSS 2 ml intravenous before surgery and every 12 hours for two days.

Interventions

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Parecoxib

Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.

Intervention Type DRUG

Control

NSS 2 ml intravenous before surgery and every 12 hours for two days.

Intervention Type OTHER

Other Intervention Names

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Dynastat

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Tanyong Pipanmekaporn

Department of Anesthesiology,Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanyong Pipanmekaporn, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200

Locations

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Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Maung, Chiang Mai, Thailand

Site Status

Department of Anesthesiology, Faculty of Medicine

Maung, Chiang Mai, Thailand

Site Status

Countries

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Thailand

References

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Bamgbade OA, Dorje P, Adhikary GS. The dual etiology of ipsilateral shoulder pain after thoracic surgery. J Clin Anesth. 2007 Jun;19(4):296-8. doi: 10.1016/j.jclinane.2006.09.010.

Reference Type BACKGROUND
PMID: 17572327 (View on PubMed)

MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.

Reference Type BACKGROUND
PMID: 18195603 (View on PubMed)

Other Identifiers

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research ID 79

Identifier Type: OTHER

Identifier Source: secondary_id

COM-10-11-19A-12

Identifier Type: -

Identifier Source: org_study_id