Laparotomy Surgery Clinical Trial
Official title:
A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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: ? ~ ? 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Peking union medical college hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ESR change | before and 42hrs and 66hrs after surgery | No | |
Other | portal blood flow change | Ultrasound evaluation | before and after surgery | No |
Other | CRP change | before and 42hrs and 66hrs after surgery | No | |
Other | IL4 change | before and 42hrs and 66hrs after surgery | No | |
Other | IL6 change | before and 42hrs and 66hrs after surgery | No | |
Other | portal blood pressure change | Ultrasound evaluation | before and after surgery | No |
Primary | VAS scores change | at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery | No | |
Secondary | liver function change | befor and 42hrs and 66hrs after surgery | No | |
Secondary | kidney function change | befor and 42hrs and 66hrs after surgery | No | |
Secondary | blood ammonia level change | before and 42hrs, 66hrs after surgery | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05288738 -
Comparing Post-Operative Analgesic Effects of PCAM With Dexmedetomidine 1 mcg/ml vs PCAM With Dexmedetomidine 2 mcg/ml
|
Phase 4 |