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The research is to test the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery by comparing Parecoxib drug and NSS administration 15 min before starting the surgery which the result of postoperative pain score is interpret by visual analog scale index
The research is working on testing the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery whether its can reduce postoperative pain score, reduce total opioid consumption in first 24 hour postoperation and reduce postoperation hospital length stay. Patients who are undergoing gynecological surgery is recruited to the research project while they admit in the hospital for preoperative preparation, in each type of surgery groups (1.Total abdominal hysterectomy 2. Adnexal surgery 3. Surgical staging) will divided in to 2 groups which is experimental group (Parecoxib) and control group (Normal saline). The experimental group will have Parecoxib administration 15 min before starting the surgery and control group will have normal saline administration 15 min before starting the surgery as same, the primary result is postoperative pain score which is interpreted by Visual analog scale index at 2,6,12,24 hour postoperation, the patients will get opioid drug (Morphine) for pain control depending on pain score index they inform, if pain score >7: morphine 0.075 mg/kg iv, if pain score 5 : morphine 0.05mg/kg iv, if pain score <5 : no morphine given. Lastly the side effect of Parecoxib drug will be observed and postoperative hospital length stay of each patient will be recorded
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Groups of patients who have Parecoxib drug administration before start surgery |
|
| Control group | Placebo Comparator | Group of patients who have normal saline (Placebo) administration before start surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parecoxib | Drug | Parecoxib administration 15 minutes before start surgical operation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain score | Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale' | 24 hour post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of opioid drug consumption | Total dose of opioid drug consumption (Morphine) in 24 hour post operation | 24 hour post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect from Parecoxib drug | observe any side effects of Parecoxib drug which are nausea, vomit and respiratory depression | 24 hour post operation |
| Total hospital length stay after operation | record total hospital length stay since post operation date to discharge date |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | Thailand |
drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
10 September 2023 to 27 June 2024
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| Normal saline |
| Drug |
Normal saline administration 15 minutes before start surgical operation |
|
| Post operation date to discharge date |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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