Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
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, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.
Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies|
- The change of shoulder pressure pain threshold [ Time Frame: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery ] [ Designated as safety issue: No ]The patients keep sitting position, and the pressure pain thresholds are measured twice at a fixed point in bilateral levator scapulae, supraspinatus, pectoralis major and flexor carpi ulnaris with a pressure algometer (FPX25, Wagner Instruments, USA) by an independent doctor.
- The severity of shoulder pain [ Time Frame: At the day before surgery, 24h and 48h after surgery ] [ Designated as safety issue: No ]The patients are asked to rate the severity of shoulder pain via a visual analog scale (VAS) ranging from no pain (0) to worst possible pain (10) by another independent doctor.
|Study Start Date:||May 2013|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Parecoxib
Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
Parecoxib 40mg will be intravenously infused.
Placebo Comparator: Placebo
Normal saline 5ml will be intravenously infused at the same time points., respectively.
Normal saline 5ml will be intravenously infused.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843010
|Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.|
|Guangzhou, Guangdong, China, 510089|
|Study Director:||Ke xuan Liu, M.D and Ph.D||1st affiliated hospital of Sun Yat-sen university|