Can Parecoxib Reduce Post-operative Ipsilateral Shoulder... | NCT01288924

Studies
Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

NCT01288924

Sponsor

Chiang Mai University

Status

Completed

Last Update Posted

Dec 6, 2016Estimated

Enrollment

160Actual

Phase

Phase 2

Conditions

Shoulder Pain
Post-operative Pain

Interventions

Parecoxib
Control

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
research ID 79	Other Identifier	Ethic committee, Faculty of Medicine, Chiang Mai University

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Oct 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 1, 2011

First Submission Date that Met QC Criteria

Feb 1, 2011

First Posted Date

Feb 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tanyong Pipanmekaporn, Department of Anesthesiology,Faculty of Medicine, Chiang Mai UniversityPrincipal Investigator

Lead Sponsor

Chiang Mai UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parecoxib	Active Comparator	Parecoxib 2 ml intravenous	Drug: Parecoxib
Control	Placebo Comparator	0.9% sodium chloride 2 ml intravenous	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parecoxib	Drug	Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.	Parecoxib

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tanyong Pipanmekaporn, MD	Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University		Maung	Chiang Mai	50200	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17572327	Background	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.
18195603	Background	MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.

ID	Term
D020069	Shoulder Pain
D010149	Pain, Postoperative

ID	Term
D018771	Arthralgia
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010146	Pain