Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Hepatic Hemangioma Located in the Right Liver; Laparotomy Surgery
• Intervention / Treatment: Drug: Parecoxib Sodium

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shunda Du, Doctor; Phone Number: 86-010-69156042; Email: shundadu@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Shunda Du, Doctor; Phone Number: 8613911832900; Email: shundadu@sina.com
      • Principal Investigator: Shunda Du, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: A; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESR change		before and 42hrs and 66hrs after surgery
portal blood flow change	Ultrasound evaluation	before and after surgery
CRP change		before and 42hrs and 66hrs after surgery
IL4 change		before and 42hrs and 66hrs after surgery
IL6 change		before and 42hrs and 66hrs after surgery
portal blood pressure change	Ultrasound evaluation	before and after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Postoperative Complications; Pain; Neurologic Manifestations; Neoplasms, Vascular Tissue; Pain, Postoperative; Hemangioma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: PUMCH-Liver-Dynastat