Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288924
• Other study ID #: COM-10-11-19A-12
• Secondary ID: research ID 79
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2011
• Last updated: December 5, 2016
• Start date: February 2011
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Shoulder Pain

Intervention

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

Other:
• Control
NSS 2 ml intravenous before surgery and every 12 hours for two days.

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine	Maung	Chiang Mai
Thailand	Department of Anesthesiology, Faculty of Medicine, Chiang Mai University	Maung	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	compare an amount of morphine consumption		at 2,6 ,12,24,48,72 and 96 hours after the operation	No
Secondary	adverse effect related to parecoxib		during 96 hours	Yes