Clinical trial NCT02204878: Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Official title: A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatic Hemangioma Located in the Right Liver
Laparotomy Surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy


Eligibility criteria: 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.

Primary outcomes:
measure: VAS scores change
timeFrame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery
Secondary outcomes:
measure: liver function change
timeFrame: befor and 42hrs and 66hrs after surgery
measure: kidney function change
timeFrame: befor and 42hrs and 66hrs after surgery
measure: blood ammonia level change
timeFrame: before and 42hrs, 66hrs after surgery
Other outcomes:
measure: ESR change
timeFrame: before and 42hrs and 66hrs after surgery
measure: portal blood flow change
timeFrame: before and after surgery
measure: CRP change
timeFrame: before and 42hrs and 66hrs after surgery
measure: IL4 change
timeFrame: before and 42hrs and 66hrs after surgery
measure: IL6 change
timeFrame: before and 42hrs and 66hrs after surgery
measure: portal blood pressure change
timeFrame: before and after surgery
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
Study officials:
References: