Pain ManagementNCT03990922
CTPVB for Hepatectomy
A study testing Continuous Paravertebral block with ropivacaine and Continuous Paravertebral "block" with saline in people with Pain Management and Paravertebral Block, run by Cui Xulei at 1 site in China.
Trial summary
Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Management, Paravertebral Block, Hepatectomy
- What is being tested?
- Continuous Paravertebral block with ropivacaine and Continuous Paravertebral "block" with saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2019to 17 Nov 2019
- 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
Official title: Continuous Thoracic Paravertebral Block for Open Hepatectomy
Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.
The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.
- Conditions
- Pain Management, Paravertebral Block, Hepatectomy
- Being tested
- Continuous Paravertebral block with ropivacaine, Continuous Paravertebral "block" with saline, Patient-controlled analgesia with morphine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Paravertebral block with ropivacaineProcedure or surgery
Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).
Continuous Paravertebral "block" with salineProcedure or surgery
Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).
Patient-controlled analgesia with morphineDrug
Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg
| Study group | Role | What they receive |
|---|---|---|
| CTPVB with ropivocaine | Experimental | Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine Receives: Procedure: Continuous Paravertebral block with ropivacaine; Drug: Patient-controlled analgesia with morphine |
| CTPVB with saline | Placebo comparator | Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine Receives: Procedure: Continuous Paravertebral "block" with saline; Drug: Patient-controlled analgesia with morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the postoperative recovery quality on postoperative day 7
The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
Measured: at the 7th postoperative day
Secondary outcomes (6)
the postoperative recovery quality on postoperative day 3
QoR-15 questionnaire The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
Measured: at the 3th postoperative day
The pain scores determined by the numeric rating scale (NRS, 0-10)
The patients evaluated their pain severity with thenumeric rating scale (NRS, 0-10),where 0 indicates no pain, and 10 indicates the most severe pain
Measured: At 8, 24,48 hours after the surgery
cumulated morphine consumption
Measured: At 8, 24,48 hours after the surgery
time to resumption of bowel movement
Measured: Up to 2 weeks after surgery
time to out-of bed activity/ambutation
Measured: Up to 2 weeks
post operative length of stay
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Jun 2019
- Primary completion9 Nov 2019
- Study completion17 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Double blind
- Who is masked
- Participant, 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
- xulei cui, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990922
- Sponsor's protocol ID
- PVB_H
- Status last verified
- Dec 2019
- First submitted
- 17 Jun 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Thoracic Paravertebral Block for Open Hepatectomy
- ClinicalTrials.gov ID
- NCT03990922
- Acronym / sponsor ID
- PVB_H
- Conditions
- Pain Management, Paravertebral Block, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cui XuleiUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 9 Nov 2019 (actual)
- Study completion
- 17 Nov 2019 (actual)
- First posted
- 19 Jun 2019 (actual)
- 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.
Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.
The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTPVB with ropivocaine | Experimental | Procedure: Continuous Paravertebral block with ropivacaine, Drug: Patient-controlled analgesia with morphineContinuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine |
| CTPVB with saline | Placebo comparator | Procedure: Continuous Paravertebral "block" with saline, Drug: Patient-controlled analgesia with morphineContinuous Paravertebral block with saline and Patient-controlled analgesia with morphine |
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 |
|---|---|---|
| Continuous Paravertebral block with ropivacaineInject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h). | Procedure or surgery | CTPVB with ropivocaine |
| Continuous Paravertebral "block" with salineInject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h). | Procedure or surgery | CTPVB with saline |
| Patient-controlled analgesia with morphineMorphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg | Drug | CTPVB with ropivocaine, CTPVB with saline |
Primary outcome
the postoperative recovery quality on postoperative day 7
Time frame: at the 7th postoperative day
The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
6 secondary outcomes
the postoperative recovery quality on postoperative day 3
Time frame: at the 3th postoperative day
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time frame: At 8, 24,48 hours after the surgery
cumulated morphine consumption
Time frame: At 8, 24,48 hours after the surgery
time to resumption of bowel movement
Time frame: Up to 2 weeks after surgery
time to out-of bed activity/ambutation
Time frame: Up to 2 weeks
post operative length of stay
Time frame: Up to 2 weeks
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 2 Jan 2020.
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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.
xulei cui, MD principal investigator
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 Continuous Paravertebral block with ropivacaine and Continuous Paravertebral "block" with saline in people with Pain Management and Paravertebral Block, 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 2 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
the postoperative recovery quality on postoperative day 7 (time frame: at the 7th postoperative day). 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 2 Jan 2020.