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The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional intravenous infusion pump
parecoxib
intravenous infusion pump of patient-controlled analgesia
fentanyl citrate+ ondansetron hydrochloride + normal saline
celecoxib
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients need laparotomic liver resection.

Exclusion Criteria:

Patients with contraindications to spinal anesthesia or intrathecal morphine, difficulty understanding passive cutaneous anaphylaxis, a history of drug dependence or chronic pain, body mass index greater than 35 kg/m2, or history of sleep apnea were excluded from this study.

Sites / Locations

  • harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

conventional intravenous infusion pump

parecoxib

new intravenous infusion pump

Arm Description

The first group receives conventional intravenous infusion pump of patient-controlled analgesia.

The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.

The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.

Outcomes

Primary Outcome Measures

The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate.
Pain scores are evaluated with a visual analog scale of 0 to 100 and are measured at rest and with movement such as cough or incentive spirometry at 6, 9, 12, 18, 24, 36, 48 and 72 hours. Sedation, nausea, and pruritus are also measured at 6, 9, 12, 18, 24, 36, 48 and 72 hours. All the measures count together to get a composite outcome.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2014
Last Updated
April 2, 2015
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02408146
Brief Title
The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

5. Study Description

Brief Summary
The investigators hypothesized that using new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) would significantly improve postoperative pain control compare to conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16 mg/8 mL + normal saline). This prospective randomized controlled trial was designed to evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) for postoperative analgesia after laparotomic liver resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional intravenous infusion pump
Arm Type
Experimental
Arm Description
The first group receives conventional intravenous infusion pump of patient-controlled analgesia.
Arm Title
parecoxib
Arm Type
Experimental
Arm Description
The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.
Arm Title
new intravenous infusion pump
Arm Type
Experimental
Arm Description
The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
Intervention Type
Procedure
Intervention Name(s)
conventional intravenous infusion pump
Intervention Description
The first group receives conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16 mg/8 mL + normal saline) for three days after surgery. The pump is infused continuously at the basic flow rate of 2 mL/h, 0.5 mL of bolus can be injected if the patients press the button once upon experiencing pain. The lock-out time for each bolus injection is 15 minutes.
Intervention Type
Drug
Intervention Name(s)
parecoxib
Other Intervention Name(s)
CAS number: 202409-33-4
Intervention Description
The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.
Intervention Type
Procedure
Intervention Name(s)
intravenous infusion pump of patient-controlled analgesia
Intervention Description
The third group has oral celecoxib before surgery, and receives 40 mg parecoxib sodium intravenously guttae immediately after surgery, then uses new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) for three days after surgery. The pump is infused continuously at the basic flow rate of 2 mL/h, 0.5 mL of bolus can be injected if the patients press the button once upon experiencing pain. The lock-out time for each bolus injection is 15 minutes.
Intervention Type
Drug
Intervention Name(s)
fentanyl citrate+ ondansetron hydrochloride + normal saline
Intervention Type
Drug
Intervention Name(s)
celecoxib
Primary Outcome Measure Information:
Title
The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate.
Description
Pain scores are evaluated with a visual analog scale of 0 to 100 and are measured at rest and with movement such as cough or incentive spirometry at 6, 9, 12, 18, 24, 36, 48 and 72 hours. Sedation, nausea, and pruritus are also measured at 6, 9, 12, 18, 24, 36, 48 and 72 hours. All the measures count together to get a composite outcome.
Time Frame
With or without changes in the three days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients need laparotomic liver resection. Exclusion Criteria: Patients with contraindications to spinal anesthesia or intrathecal morphine, difficulty understanding passive cutaneous anaphylaxis, a history of drug dependence or chronic pain, body mass index greater than 35 kg/m2, or history of sleep apnea were excluded from this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lianxin Liu, M.D.
Phone
86-451-85553886
Ext
3886
Email
liulianxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiabei Wang, PhD
Phone
86-451-85555048
Ext
5048
Email
inn_2001@126.com
Facility Information:
Facility Name
harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiabei Wang, PhD
Phone
86-451-85555049
Email
inn_2001@126.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection

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