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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288924

Enrollment

160

Registered

2011-02-03

Start date

2011-02-28

Completion date

2016-01-31

Last updated

2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain, Shoulder Pain

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.

Interventions

DRUGParecoxib

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

OTHERControl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026