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Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

Primary Purpose

Shoulder Pain, Post-operative Pain

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Parecoxib
Control
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
  • Department of Anesthesiology, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Parecoxib

Control

Arm Description

Parecoxib 2 ml intravenous

0.9% sodium chloride 2 ml intravenous

Outcomes

Primary Outcome Measures

Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement

Secondary Outcome Measures

compare an amount of morphine consumption
adverse effect related to parecoxib

Full Information

First Posted
February 1, 2011
Last Updated
December 5, 2016
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT01288924
Brief Title
Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?
Official Title
Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Post-operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parecoxib
Arm Type
Active Comparator
Arm Description
Parecoxib 2 ml intravenous
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride 2 ml intravenous
Intervention Type
Drug
Intervention Name(s)
Parecoxib
Other Intervention Name(s)
Dynastat
Intervention Description
Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
NSS 2 ml intravenous before surgery and every 12 hours for two days.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement
Time Frame
at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation
Secondary Outcome Measure Information:
Title
compare an amount of morphine consumption
Time Frame
at 2,6 ,12,24,48,72 and 96 hours after the operation
Title
adverse effect related to parecoxib
Time Frame
during 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanyong Pipanmekaporn, MD
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
City
Maung
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Department of Anesthesiology, Faculty of Medicine
City
Maung
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17572327
Citation
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.
Results Reference
background
PubMed Identifier
18195603
Citation
MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.
Results Reference
background

Learn more about this trial

Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

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