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

NCT ID: NCT02408146

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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conventional intravenous infusion pump

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

Group Type EXPERIMENTAL

conventional intravenous infusion pump

Intervention Type PROCEDURE

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.

fentanyl citrate+ ondansetron hydrochloride + normal saline

Intervention Type DRUG

parecoxib

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

Group Type EXPERIMENTAL

parecoxib

Intervention Type DRUG

The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.

celecoxib

Intervention Type DRUG

new intravenous infusion pump

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

Group Type EXPERIMENTAL

parecoxib

Intervention Type DRUG

The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.

intravenous infusion pump of patient-controlled analgesia

Intervention Type PROCEDURE

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.

celecoxib

Intervention Type DRUG

Interventions

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conventional intravenous infusion pump

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 PROCEDURE

parecoxib

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 DRUG

intravenous infusion pump of patient-controlled analgesia

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 PROCEDURE

fentanyl citrate+ ondansetron hydrochloride + normal saline

Intervention Type DRUG

celecoxib

Intervention Type DRUG

Other Intervention Names

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CAS number: 202409-33-4

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lianxin Liu, M.D.

Role: CONTACT

86-451-85553886 ext. 3886

Jiabei Wang, PhD

Role: CONTACT

86-451-85555048 ext. 5048

Facility Contacts

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Jiabei Wang, PhD

Role: primary

86-451-85555049

Other Identifiers

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Lianxin-001

Identifier Type: -

Identifier Source: org_study_id

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