Hepatic Hemangioma Located in the Right Liver, Laparotomy Surgery
Conditions
Brief summary
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
Interventions
DRUGParecoxib Sodium
Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS scores change | at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery |
Secondary
| Measure | Time frame |
|---|---|
| liver function change | befor and 42hrs and 66hrs after surgery |
| kidney function change | befor and 42hrs and 66hrs after surgery |
| blood ammonia level change | before and 42hrs, 66hrs after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| IL6 change | before and 42hrs and 66hrs after surgery | — |
| ESR change | before and 42hrs and 66hrs after surgery | — |
| portal blood pressure change | before and after surgery | Ultrasound evaluation |
| portal blood flow change | before and after surgery | Ultrasound evaluation |
| CRP change | before and 42hrs and 66hrs after surgery | — |
| IL4 change | before and 42hrs and 66hrs after surgery | — |
Countries
China
Contacts
Primary ContactShunda Du, Doctor
Outcome results
None listed