HepatectomyNCT02817321
Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision
A study testing single-injection TPVB + continuous TPVB, Philip CX50 Ultrasound Scanner and PAJUNK Contiplex S Catheter in people with Hepatectomy and Analgesia, run by Cui Xulei at 1 site in China.
Trial summary
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatectomy, Analgesia, Nerve Block
- What is being tested?
- single-injection TPVB + continuous TPVB, Philip CX50 Ultrasound Scanner and PAJUNK Contiplex S Catheter
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2018
- 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
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo hepatectomy with J-shape subcostal incision
- Informed consent
Who cannot join
- A known allergy to the drugs being used
- Coagulopathy, on anticoagulants
- Analgesics intake, history of substance abuse
- Participating in the investigation of another experimental agent
- Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Trial locations and contacts
1 site in 1 country.
About this study
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.
- Conditions
- Hepatectomy, Analgesia, Nerve Block
- Being tested
- single-injection TPVB + continuous TPVB, Philip CX50 Ultrasound Scanner, PAJUNK Contiplex S Catheter, single dose ropivacaine, continuously infusion of ropivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-injection TPVB + continuous TPVBProcedure or surgery
Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Philip CX50 Ultrasound ScannerDevice
The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
PAJUNK Contiplex S CatheterDevice
single dose ropivacaineDrug
- 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total
- given immediately after the correct position of the tip of the needle has been confirmed
continuously infusion of ropivacaineDrug
- 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes
- given through the catheter inserted in the T8 paravertebral space following the single dose
Morphine given as IPCADrug
bolus: 2mg, lock time: 10min, 1h limitation: 8mg
| Study group | Role | What they receive |
|---|---|---|
| Single-injection TPVB +continuous TPVB | Experimental | Single-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA. Receives: Procedure: single-injection TPVB + continuous TPVB; Device: Philip CX50 Ultrasound Scanner; Device: PAJUNK Contiplex S Catheter; Drug: single dose ropivacaine; Drug: continuously infusion of ropivacaine; Drug: Morphine given as IPCA |
| IPCA | Active comparator | postoperative IPCA is given alone Receives: Drug: Morphine given as IPCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative morphine consumption
Measured: within 48 postoperative hours
Secondary outcomes (8)
The pain scores determined by the numeric rating scale (NRS, 0-10)
Measured: At 0, 2,4, 8, 12, 24 ,48,72hours and 7day after the surgery
nausea and vomiting score
Measured: At 0, 2,4, 8, 12, 24 and 48hours after the surgery
pruritus score
Measured: At 0, 2,4, 8, 12, 24 and 48hours after the surgery
ambulation time
Measured: within the 7 days after surgery
time of recovery of bowl movement
Measured: within the 7 days after surgery
Postoperative hospital length of stay
Measured: Up to 4 weeks
patient satisfaction with anesthesia
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia
Measured: 48 hours after surgery
data collection of chronic pain
Patients undergo a telephone interview with a questionnaire at 3, 6 and 12 months after surgery, the incidence and severity of chronic pain is recorded.
Measured: at 3,6,12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startNov 2016
- Primary completion31 Oct 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cui Xulei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Xulei, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, MD., Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817321
- Sponsor's protocol ID
- cuixulei2
- Status last verified
- Jan 2019
- First submitted
- 22 Jun 2016
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision
- ClinicalTrials.gov ID
- NCT02817321
- Acronym / sponsor ID
- cuixulei2
- Conditions
- Hepatectomy, Analgesia, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cui XuleiUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 29 Jun 2016 (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.
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-injection TPVB +continuous TPVB | Experimental | Procedure: single-injection TPVB + continuous TPVB, Device: Philip CX50 Ultrasound Scanner, Device: PAJUNK Contiplex S Catheter, Drug: single dose ropivacaine, Drug: continuously infusion of ropivacaine, Drug: Morphine given as IPCASingle-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA. |
| IPCA | Active comparator | Drug: Morphine given as IPCApostoperative IPCA is given alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo hepatectomy with J-shape subcostal incision
- Informed consent
Key exclusion criteria (5 listed)
- A known allergy to the drugs being used
- Coagulopathy, on anticoagulants
- Analgesics intake, history of substance abuse
- Participating in the investigation of another experimental agent
- Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
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 |
|---|---|---|
| single-injection TPVB + continuous TPVBInject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. | Procedure or surgery | Single-injection TPVB +continuous TPVB |
| Philip CX50 Ultrasound ScannerThe curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning | Device | Single-injection TPVB +continuous TPVB |
| PAJUNK Contiplex S Catheter | Device | Single-injection TPVB +continuous TPVB |
| single dose ropivacaine* 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total * given immediately after the correct position of the tip of the needle has been confirmed | Drug | Single-injection TPVB +continuous TPVB |
| continuously infusion of ropivacaine* 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes * given through the catheter inserted in the T8 paravertebral space following the single dose | Drug | Single-injection TPVB +continuous TPVB |
| Morphine given as IPCAbolus: 2mg, lock time: 10min, 1h limitation: 8mg | Drug | IPCA, Single-injection TPVB +continuous TPVB |
Primary outcome
cumulative morphine consumption
Time frame: within 48 postoperative hours
8 secondary outcomes
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time frame: At 0, 2,4, 8, 12, 24 ,48,72hours and 7day after the surgery
nausea and vomiting score
Time frame: At 0, 2,4, 8, 12, 24 and 48hours after the surgery
pruritus score
Time frame: At 0, 2,4, 8, 12, 24 and 48hours after the surgery
ambulation time
Time frame: within the 7 days after surgery
time of recovery of bowl movement
Time frame: within the 7 days after surgery
Postoperative hospital length of stay
Time frame: Up to 4 weeks
patient satisfaction with anesthesia
Time frame: 48 hours after surgery
data collection of chronic pain
Time frame: at 3,6,12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Yuguang Huang, MD. study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-injection TPVB + continuous TPVB, Philip CX50 Ultrasound Scanner and PAJUNK Contiplex S Catheter in people with Hepatectomy and Analgesia, run by Cui Xulei 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative morphine consumption (time frame: within 48 postoperative hours). 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 8 Jan 2019.