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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parecoxib | Active Comparator | Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery. |
|
| Placebo | Placebo Comparator | Normal saline 5ml will be intravenously infused at the same time points., respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parecoxib | Drug | Parecoxib 40mg will be intravenously infused. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change of shoulder pressure pain threshold | 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 pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The severity of shoulder pain | 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. | At the day before surgery, 24h and 48h after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ke xuan Liu, M.D and Ph.D | 1st affiliated hospital of Sun Yat-sen university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University. | Guangzhou | Guangdong | 510089 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23136538 | Background | Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23. |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
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| Placebo |
| Drug |
Normal saline 5ml will be intravenously infused. |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |