NCT01288924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

4.7 years

First QC Date

February 1, 2011

Last Update Submit

December 5, 2016

Conditions

Shoulder PainPost-operative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Study Arms (2)

Parecoxib

ACTIVE COMPARATOR

Parecoxib 2 ml intravenous

Drug: Parecoxib

Control

PLACEBO COMPARATOR

0.9% sodium chloride 2 ml intravenous

Other: Control

Interventions

ParecoxibDRUG

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

Also known as: Dynastat
Parecoxib
ControlOTHER

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

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology (ASA) physical status I-III
  • Undergoing pulmonary resection by open thoracotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Maung, Chiang Mai, 50200, Thailand

Location

Department of Anesthesiology, Faculty of Medicine

Maung, Chiang Mai, 50200, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 17572327BACKGROUND

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

    PMID: 18195603BACKGROUND

MeSH Terms

Conditions

Shoulder PainPain, Postoperative

Interventions

parecoxib

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Tanyong Pipanmekaporn, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology,Faculty of Medicine

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 3, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)