Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Study Overview
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Brief Summary
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To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy

Official Title
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A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Conditions
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Hepatic Hemangioma Located in the Right Liver, Laparotomy Surgery

Intervention / Treatment
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* Drug: Parecoxib Sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>1ml of saline 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. 1ml saline Q12h will be given within 72 hours after surgery | |
| Experimental: AT<br>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 | Drug: Parecoxib Sodium<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scores change |  | at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |