Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

Chiang Mai University

Status and phase: Completed; Phase 2

Conditions: Shoulder Pain; Post-operative Pain

Treatments: Other: Control; Drug: Parecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT01288924

COM-10-11-19A-12

research ID 79 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups, including a placebo group

Parecoxib

Active Comparator group

Description:

Parecoxib 2 ml intravenous

Treatment:

Drug: Parecoxib

Control

Placebo Comparator group

Description:

0.9% sodium chloride 2 ml intravenous

Treatment:

Other: Control