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Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288924
First Posted: February 3, 2011
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tanyong Pipanmekaporn, Chiang Mai University
  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 Other: Control Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Tanyong Pipanmekaporn, 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 ]

Secondary Outcome Measures:
  • compare an amount of morphine consumption [ Time Frame: at 2,6 ,12,24,48,72 and 96 hours after the operation ]
  • adverse effect related to parecoxib [ Time Frame: during 96 hours ]

Enrollment: 160
Study Start Date: February 2011
Study Completion Date: January 2016
Primary Completion Date: October 2015 (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
Other: Control
NSS 2 ml intravenous before surgery and every 12 hours for two days.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288924


Locations
Thailand
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
Maung, Chiang Mai, Thailand, 50200
Department of Anesthesiology, Faculty of Medicine
Maung, Chiang Mai, Thailand, 50200
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 ( Other Identifier: Ethic committee, Faculty of Medicine, Chiang Mai University )
First Submitted: February 1, 2011
First Posted: February 3, 2011
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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