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Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Primary Purpose

Hepatic Hemangioma Located in the Right Liver, Laparotomy Surgery

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Parecoxib Sodium
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Hemangioma Located in the Right Liver

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking union medical college hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

AT

Arm 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

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

Outcomes

Primary Outcome Measures

VAS scores change

Secondary Outcome Measures

liver function change
kidney function change
blood ammonia level change

Full Information

First Posted
July 28, 2014
Last Updated
July 29, 2014
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02204878
Brief Title
Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Official Title
A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Hemangioma Located in the Right Liver, Laparotomy Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm 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
Arm Title
AT
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Parecoxib Sodium
Intervention 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
Primary Outcome Measure Information:
Title
VAS scores change
Time Frame
at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery
Secondary Outcome Measure Information:
Title
liver function change
Time Frame
befor and 42hrs and 66hrs after surgery
Title
kidney function change
Time Frame
befor and 42hrs and 66hrs after surgery
Title
blood ammonia level change
Time Frame
before and 42hrs, 66hrs after surgery
Other Pre-specified Outcome Measures:
Title
ESR change
Time Frame
before and 42hrs and 66hrs after surgery
Title
portal blood flow change
Description
Ultrasound evaluation
Time Frame
before and after surgery
Title
CRP change
Time Frame
before and 42hrs and 66hrs after surgery
Title
IL4 change
Time Frame
before and 42hrs and 66hrs after surgery
Title
IL6 change
Time Frame
before and 42hrs and 66hrs after surgery
Title
portal blood pressure change
Description
Ultrasound evaluation
Time Frame
before and after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shunda Du, Doctor
Phone
86-010-69156042
Email
shundadu@sina.com
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunda Du, Doctor
Phone
8613911832900
Email
shundadu@sina.com
First Name & Middle Initial & Last Name & Degree
Shunda Du, Doctor

12. IPD Sharing Statement

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Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

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