Status:
UNKNOWN
Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Hepatic Hemangioma Located in the Right Liver
Laparotomy Surgery
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief Summary
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
Eligibility Criteria
Inclusion
- Age between 20-70 years old;
- Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic hemangioma between 5-15cm, located in the right liver;
- Child score 5-6;
- BMI: 19-25;
- ASA: Ⅰ \~ Ⅱ grade;
- No comorbidities such as diabetes, hypertension, cardio renal or respiratory dysfunction, mental illness;
- No known allergies;
- No participation in other clinical trials within 2 months;
- Have been informed consent.
- Surgery-related: right subcostal incision, surgical time\< 4 hours, hepatic pedicle occlusion time\< 20 minutes, bleeding\< 1000ml, no blood transfusions.
Exclusion
- History of chronic pain，long-term use of analgesic drugs or alcohol abuse;
- Allergic to NSAIDs, opioids or sulfa drugs;
- Coagulopathy or other hematological disorder；
- Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;
- Pregnant or lactating;
- Mentally unstable to use PCA;
- Preoperative pain caused by other disease;
- Analgesic drugs or NSAIDs intake one week before surgery;
- Preoperative systemic inflammatory response syndrome;
- Preoperative chemotherapy or radiotherapy;
- Preoperative or postoperative use of steroids;
- Operative time\> 4 hours, hepatic pedicle occlusion time\> 20 minutes, blood loss\> 1000ml, or intraoperative blood transfusion;
- TBil\> 34 umol/L、PT prolongation\> 3S、ALB\< 30 g/L、or Child score\> 7 within 42 hours after surgery；
- Bleeding、biliary fistula, intra-abdominal infections or other postoperative complications.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02204878
Start Date
July 1 2014
Last Update
July 30 2014
Active Locations (1)
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1
Peking union medical college hospital
Beijing, Beijing Municipality, China, 100032