Clinical trial NCT01288924: Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?
Official title: Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Pain
Post-operative Pain
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement
timeFrame: at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation
Secondary outcomes:
measure: compare an amount of morphine consumption
timeFrame: at 2,6 ,12,24,48,72 and 96 hours after the operation
measure: adverse effect related to parecoxib
timeFrame: during 96 hours
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
state: Chiang Mai
city: Maung
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine
state: Chiang Mai
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
name: Tanyong Pipanmekaporn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.