Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
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 (e.g. 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 Inventory(BPI) questionnaire.
Anti-Inflammatory Agents, Non-Steroidal
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- The incidence of shoulder pain [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Experimental: parecoxib, normal saline||
parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
|Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university|
|Guangzhou, Guangdong, China, 510080|