Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Post-operative Pain
• Intervention / Treatment: Drug: Parecoxib; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parecoxib; Parecoxib 2 ml intravenous	Drug: Parecoxib; Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Tanyong Pipanmekaporn, MD, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain, Postoperative; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: COM-10-11-19A-12; research ID 79 (Other Identifier: Ethic committee, Faculty of Medicine, Chiang Mai University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO