Gynecological Surgery, Parecoxib, Postoperative Pain, Preemptive Analgesia
Conditions
Keywords
Preemptive analgesia, Gynecological surgery, Parecoxib, Postoperative pain
Brief summary
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
Detailed description
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
Interventions
DRUGParecoxib
Parecoxib administration 15 minutes before start surgical operation
DRUGNormal saline
Normal saline administration 15 minutes before start surgical operation
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients age between 18-70 year-old, who participate in explor lap gynecological surgery (Hysterectomy, Adnexal surgery and surgical stagings) using general anesthesia technique * American society of Anesthesiologists physical status grade I-II * Capable to communicate in Thai language
Exclusion criteria
* Allergic to NSAIDs and opioid * Allergic to Parecoxib drug * Underlying neuropathic pain * Pregnant woman or woman who undergoes breast feeding * Uncontrolled hypertension disease, BP \>160/110 at admission date * Underlying ischemic heart disease, Ischemic stroke or peripheral arterial disease * History status post coronary artery bypass grafting * Patients who take Aspirin within 7 days before surgery date * Had underlying which is contraindiated to NSAIDs drug such as Gastritis, history of GI ulcer, chronic kidney disease (Cr clearance \< 30ml/min), liver cirrhosis (Child-Pugh class B or above/ serum albumin \< 25 g/l) * Patients who had NSAIDs drug while admit in hospital for preparing the operation before surgery date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain score | 24 hour post operation | Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of opioid drug consumption | 24 hour post operation | Total dose of opioid drug consumption (Morphine) in 24 hour post operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effect from Parecoxib drug | 24 hour post operation | observe any side effects of Parecoxib drug which are nausea, vomit and respiratory depression |
| Total hospital length stay after operation | Post operation date to discharge date | record total hospital length stay since post operation date to discharge date |
Countries
Thailand
Outcome results
None listed