Nerve BlockNCT03777644
Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
A study testing Continuous Paravertebral block with ropivacaine and Continuous Paravertebral Block with Saline in people with Nerve 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
- Nerve Block
- 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
- 1 Nov 2018to 19 May 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: Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After 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
- Nerve Block
- Being tested
- Continuous Paravertebral block with ropivacaine, Continuous Paravertebral Block with Saline, Patient-controlled analgesia with morphine
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 local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Continuous Paravertebral Block with SalineProcedure or surgery
Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose
Patient-controlled analgesia with morphineDrug
Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
| Study group | Role | What they receive |
|---|---|---|
| TPVB + PCA | 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 |
| placebo TPVB + PCA | 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 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
post operative length of stay
Measured: Up to 2 weeks
time to out-of bed activity/ambutation
Measured: Up to 2 weeks
time to resumption of bowel movement
Measured: Up to 2 weeks after surgery
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Nov 2018
- Primary completion12 May 2019
- Study completion19 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Health services research
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777644
- Sponsor's protocol ID
- cuixulei7
- Status last verified
- Jun 2020
- First submitted
- 10 Dec 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
- ClinicalTrials.gov ID
- NCT03777644
- Acronym / sponsor ID
- cuixulei7
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cui XuleiUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 19 May 2019 (actual)
- First posted
- 17 Dec 2018 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPVB + PCA | Experimental | Procedure: Continuous Paravertebral block with ropivacaine, Drug: Patient-controlled analgesia with morphineContinuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine |
| placebo TPVB + PCA | 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 local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg | Procedure or surgery | TPVB + PCA |
| Continuous Paravertebral Block with SalineInject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose | Procedure or surgery | placebo TPVB + PCA |
| Patient-controlled analgesia with morphineDrug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg | Drug | TPVB + PCA, placebo TPVB + PCA |
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 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
post operative length of stay
Time frame: Up to 2 weeks
time to out-of bed activity/ambutation
Time frame: Up to 2 weeks
time to resumption of bowel movement
Time frame: Up to 2 weeks after surgery
the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire
Time frame: at the 3th postoperative day
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 25 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nerve 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 25 Jun 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 25 Jun 2020.