Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chiang Mai University
Sponsor:
Information provided by (Responsible Party):
Tanyong Pipanmekaporn, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01288924
First received: February 1, 2011
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Shoulder Pain
Post-operative Pain
Drug: Parecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • compare an amount of morphine consumption [ Time Frame: at 2,6 ,12,24,48,72 and 96 hours after the operation ] [ Designated as safety issue: No ]
  • adverse effect related to parecoxib [ Time Frame: during 96 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Parecoxib
Parecoxib 2 ml intravenous
Drug: Parecoxib
Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.
Other Name: Dynastat
Placebo Comparator: Control
0.9% sodium chloride 2 ml intravenous

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288924

Contacts
Contact: Tanyong Pipanmekaporn, MD +66817648677 tanyong24@yahoo.com

Locations
Thailand
Department of Anesthesiology, Faculty of Medicine Recruiting
Maung, Chiang Mai, Thailand, 50200
Contact: Tanyong Pipanmekaporn, MD    +66817648677    tanyong24@yahoo.com   
Contact: Yodying Punjasawadwong, MD    +66819928082    ypunjasa@gmail.com   
Principal Investigator: Tanyong Pipanmekaporn, MD.         
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University Recruiting
Maung, Chiang Mai, Thailand, 50200
Contact: Tanyong Pipanmekaporn, MD.    +6653945522-6    tanyong24@yahoo.com   
Contact: Yodying Punjasawadwong, MD.    +6653945522-6    ypunjasa@gmail.com   
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Tanyong Pipanmekaporn, MD Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
  More Information

Publications:
Responsible Party: Tanyong Pipanmekaporn, Department of Anesthesiology,Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01288924     History of Changes
Other Study ID Numbers: COM-10-11-19A-12, research ID 79
Study First Received: February 1, 2011
Last Updated: November 23, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Pain, Postoperative
Shoulder Pain
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 29, 2014