Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

NCT ID: NCT02204878

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

Brief Summary

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

Conditions

Hepatic Hemangioma Located in the Right Liver; Laparotomy Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Parecoxib Sodium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking union medical college hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shunda Du, Doctor

Role: CONTACT

shundadu@sina.com

86-010-69156042

Facility Contacts

Shunda Du, Doctor

Role: primary

shundadu@sina.com

8613911832900

Other Identifiers

PUMCH-Liver-Dynastat

Identifier Type: -

Identifier Source: org_study_id