Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01393925
Status:
COMPLETED
Last Update Posted:
2011-11-22
First Post:
2011-07-11
Brief Title:
Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective double blind placebo-controlled parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou China Patients aged 18-65 ASA I-II undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study According to previous studies and our pilot trial the sample size was estimated to be 120 subjects All eligible patients will be randomly assigned to one of three groups Group A single parecoxib receiving parecoxib 40mg at 30min before the end of surgery Group B multiple parecoxib receiving parecoxib 40mg at 30min before the end of surgery at 8h and 20h after the surgery respectively and Group C Control group receiving normal saline All patients will be managed by a standard propofol-remifentanil based total intravenous anesthesia protocol The incidence and intensity of shoulder pain at rest and with motion will be evaluated by an independent doctor blinding to medication and grouping using visual analog scale VAS at 6h 24h and 48h postoperatively Other types of pain eg trocar wound and visceral pain side effects such as postoperative nausea and vomiting itching dizziness and oversedation will be assessed as well At the end of the observation the intensity of the maximum pain will be recorded and the effect of shoulder pain on the four variables regarding to quality of life activity mood walking and sleep will be assessed using modified Brief Pain InventoryBPI questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None