Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Laparotomy Surgery; Hepatic Hemangioma Located in the Right Liver

Treatments: Drug: Parecoxib Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02204878

PUMCH-Liver-Dynastat

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

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

AT

Experimental group

Description:

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

Treatment:

Drug: Parecoxib Sodium