Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Phase 4

• Conditions: Laparotomy Surgery; Hepatic Hemangioma Located in the Right Liver
• Interventions: Drug: Parecoxib Sodium

• Registration Number: NCT02204878
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-29
• Last Update Submitted: 2014-07-29
• Study First Posted: 2014-07-30
• Last Update Posted: 2014-07-30
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AT	Parecoxib 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

Primary Outcome Measures

Name	Time	Method
VAS scores change	at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Beijing, China