Skip to main content
OpenTrials
Completed

NCT Number: NCT01288924

Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Anesthesiology, Faculty of Medicine, Maung, Chiang Mai, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parecoxib

Drug

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

Other names: Dynastat

Control

Other

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

Primary outcomes

  1. 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 outcomes

  1. compare an amount of morphine consumption

    Time frame: at 2,6 ,12,24,48,72 and 96 hours after the operation

  2. adverse effect related to parecoxib

    Time frame: during 96 hours

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Feb 3, 2011
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.