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

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ClinicalTrials.gov Identifier: NCT02408146
Recruitment Status : Unknown
Verified March 2014 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: conventional intravenous infusion pump Drug: parecoxib Procedure: intravenous infusion pump of patient-controlled analgesia Drug: fentanyl citrate+ ondansetron hydrochloride + normal saline Drug: celecoxib Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: conventional intravenous infusion pump
The first group receives conventional intravenous infusion pump of patient-controlled analgesia.
Procedure: 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.

Drug: fentanyl citrate+ ondansetron hydrochloride + normal saline
Experimental: parecoxib
The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.
Drug: 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.
Other Name: CAS number: 202409-33-4

Drug: celecoxib
Experimental: new intravenous infusion pump
The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
Drug: 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.
Other Name: CAS number: 202409-33-4

Procedure: 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.

Drug: celecoxib



Primary Outcome Measures :
  1. The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate. [ Time Frame: With or without changes in the three days after surgery ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408146


Contacts
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Contact: Lianxin Liu, M.D. 86-451-85553886 ext 3886 liulianxin@hotmail.com
Contact: Jiabei Wang, PhD 86-451-85555048 ext 5048 inn_2001@126.com

Locations
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China, Heilongjiang
harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150086
Contact: Jiabei Wang, PhD    86-451-85555049    inn_2001@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02408146     History of Changes
Other Study ID Numbers: Lianxin-001
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2014

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Celecoxib
Parecoxib
Ondansetron
Citric Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents