Pain, PostoperativeNCT02408146
The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection
A study testing conventional intravenous infusion pump, parecoxib and fentanyl citrate+ ondansetron hydrochloride + normal saline in people with Pain, Postoperative, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial 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 +… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- conventional intravenous infusion pump, parecoxib and fentanyl citrate+ ondansetron hydrochloride + normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients need laparotomic liver resection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
harbin Medical University
Harbin, Heilongjiang, 150086
Jiabei Wang, PhD, 86-451-85555049, inn_2001@126.com
About this study
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.
- Conditions
- Pain, Postoperative
- Being tested
- conventional intravenous infusion pump, parecoxib, intravenous infusion pump of patient-controlled analgesia, fentanyl citrate+ ondansetron hydrochloride + normal saline, celecoxib
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional intravenous infusion pumpProcedure or surgery
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.
parecoxibDrug
Also called CAS number: 202409-33-4
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 analgesiaProcedure or surgery
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.
fentanyl citrate+ ondansetron hydrochloride + normal salineDrug
celecoxibDrug
| Study group | Role | What they receive |
|---|---|---|
| conventional intravenous infusion pump | Experimental | The first group receives conventional intravenous infusion pump of patient-controlled analgesia. Receives: Procedure: conventional intravenous infusion pump; Drug: fentanyl citrate+ ondansetron hydrochloride + normal saline |
| parecoxib | Experimental | The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery. Receives: Drug: parecoxib; Drug: celecoxib |
| new intravenous infusion pump | Experimental | The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery. Receives: Drug: parecoxib; Procedure: intravenous infusion pump of patient-controlled analgesia; Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: With or without changes in the three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408146
- Sponsor's protocol ID
- Lianxin-001
- Status last verified
- Mar 2014
- First submitted
- 1 Apr 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection
- ClinicalTrials.gov ID
- NCT02408146
- Acronym / sponsor ID
- Lianxin-001
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional intravenous infusion pump | Experimental | Procedure: conventional intravenous infusion pump, Drug: fentanyl citrate+ ondansetron hydrochloride + normal salineThe first group receives conventional intravenous infusion pump of patient-controlled analgesia. |
| parecoxib | Experimental | Drug: parecoxib, Drug: celecoxibThe second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery. |
| new intravenous infusion pump | Experimental | Drug: parecoxib, Procedure: intravenous infusion pump of patient-controlled analgesia, Drug: celecoxibThe third group uses new intravenous infusion pump of patient-controlled analgesia after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients need laparotomic liver resection.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional intravenous infusion pumpThe 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. | Procedure or surgery | conventional intravenous infusion pump |
| parecoxibAlso: CAS number: 202409-33-4The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery. | Drug | new intravenous infusion pump, parecoxib |
| intravenous infusion pump of patient-controlled analgesiaThe 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. | Procedure or surgery | new intravenous infusion pump |
| fentanyl citrate+ ondansetron hydrochloride + normal saline | Drug | conventional intravenous infusion pump |
| celecoxib | Drug | new intravenous infusion pump, parecoxib |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional intravenous infusion pump, parecoxib and fentanyl citrate+ ondansetron hydrochloride + normal saline in people with Pain, Postoperative, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lianxin Liu, M.D. (86-451-85553886 ext. 3886, liulianxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.