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Paravertebral BlockNCT04304274

Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

A study testing Paravertebral block-ropivacaine and Paravertebral block-saline in people with Paravertebral Block and Hepatectomy, run by Cui Xulei at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hepatectomy induces moderate to severe postoperative pain. Patient-controlled intravenous analgesia has been used in many medical centers for post-hepatectomy analgesia, but the effects are limited and often cause undesirable adverse effects. Regional Block has been used for postoperative analgesia in many surgeries. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Paravertebral Block, Hepatectomy, Analgesia
What is being tested?
Paravertebral block-ropivacaine and Paravertebral block-saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteChina
Study dates
10 Mar 2020to 10 Dec 2021
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
  • Unable to cooperate, eg. inability to properly describe postoperative pain to investigators

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing

Other trials in China

About this study

Official title: Early and Late Postoperative Analgesia and Recovery Effects of Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy: A Prospective, Randomized, Double-blinded, Controlled Study

Hepatectomy induces moderate to severe postoperative pain. Patient-controlled intravenous analgesia has been used in many medical centers for post-hepatectomy analgesia, but the effects are limited and often cause undesirable adverse effects.

Regional Block has been used for postoperative analgesia in many surgeries. Some studies suggest that regional analgesia has an opioid-sparing effect and can reduce the incidence of chronic pain. Also, the programmed intermittent bolus infusion is better than continuous infusion, with less analgesic consumption and fewer adverse effects.

Studies on the early and late postoperative analgesia and recovery effects of paravertebral block for open hepatectomy are scarce. Therefore, the investigators aim to conduct a prospective, randomized, subject and assessor-blinded, parallel-group, placebo-controlled study to test the hypothesis that the programmed intermittent bolus infusion of right thoracic paravertebral block reduces postoperative intravenous analgesic use and pain scores and improved patients' satisfaction.

Read the detailed description

This study aims to compare the early postoperative morphine consumptions, pain scores, rescue analgesics, adverse effects and recovery indices, and the late postoperative life quality between patients with and without paravertebral block.

Being tested
Paravertebral block-ropivacaine, Paravertebral block-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.

  • Paravertebral block-ropivacaineProcedure or surgery

    Also called PVB group

    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)

  • Paravertebral block-salineProcedure or surgery

    Also called Control group

    Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% saline infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h)

  • patient controlled analgesia with morphineDrug

    Also called PCIA

    Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg

Study groups in NCT04304274
Study groupRoleWhat they receive
PTPVB-ropivacaineExperimentalProgrammed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine
Receives: Procedure: Paravertebral block-ropivacaine; Drug: patient controlled analgesia with morphine
PTPVB-salinePlacebo comparatorProgrammed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine
Receives: Procedure: Paravertebral block-saline; Drug: patient controlled analgesia with morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative 48hrs morphine

    Cumulate morphine consumption 48 hours after hepatectomy

    Measured: Postoperative 48 hours

Secondary outcomes (17)

  1. Heart rate

    The average value of the heart rate during the operation measured at 10 minutes interval

    Measured: During the operation

  2. Mean blood pressure

    The average value of the mean blood pressure (=1/3 systolic pressure + 2/3 diastolic pressure) during the operation measured at 10 minutes interval.

    Measured: During the operation

  3. Sevoflurane concentration

    The average value of the sevoflurane concentration during the operation measured at 10 minutes interval

    Measured: During the operation

  4. Intraoperative medication dose

    Doses of fentanyl, ephedrine, atrophin, phylepherine and urapidil used during the operation

    Measured: During the operation

  5. Fluid volumes

    Fluid volumes including volumes of crystalloid, colloid, red blood cells, plasma, platelet, Urine and hemorrhage.

    Measured: During the operation

  6. Awake and extubation time

    Time from stop of sevoflurane use to patient awake and extubation.

    Measured: At the end of the operation

  7. Postoperative morphine consumption

    Cumulative morphine consumption at 2, 4, 12, 24 hours after hepatectomy

    Measured: Postoperative 2, 4, 12, 24hours

  8. Operation time

    Time from the start to the end of the operation

    Measured: During the operation

  9. The pain scores(at rest and with cough) determined by the numeric rating scale

    NRS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.

    Measured: Postoperative 0, 2, 4, 12, 24 and 48 hours

  10. Adverse effects

    Adverse effects of morphine including nausea, vomiting, pruritus and respiratory depression, bowel movement and Foley catheter removal.

    Measured: Postoperative 0-48 hours

  11. Rescue analgesia

    Times of rescue analgesia

    Measured: Postoperative 0-48hours

  12. Postoperative recovery indices

    Postoperative recovery indices including drowsiness, thirsty, cold feeling, cognitive decline and shiver evaluated using a 0-3 points Likert scale, with 0 defined as none, 1 defined as mild, 2 defined as moderate and 3 defined as severe.

    Measured: Postoperative 48 hours

  13. Satisfaction indices

    Emergence, analgesia and overall satisfaction evaluated using a 1-5 points Likert scale, with 1 defined as very unsatisfied, 2 defined as unsatisfied, 3 defined as no comments, 4 defined as satisfied and 5 defined as very satisfied.

    Measured: Postoperative 48 hours

  14. Length of hospital stay

    Number of in-hospital days from admission to discharge

    Measured: Two weeks after hospital discharge

  15. Chronic recovery data

    Chronic recovery data including incidence of pain, numbness, hypoesthesia and sleep disorder

    Measured: Postoperative 3 months

  16. Chronic pain characteristics

    Incidence of difference types of pain including throbbing, aching, pricking and stabbing.

    Measured: Postoperative 3 months

  17. Chronic pain NRS score

    NRS is an internationally recognised pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.

    Measured: Postoperative 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start10 Mar 2020
  3. Primary completion10 Jun 2021
  4. Study completion10 Dec 2021

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04304274
Sponsor's protocol ID
PTPVB-H
Status last verified
Feb 2022
First submitted
5 Mar 2020
Last updated
18 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang J, Cui X, Zhang Y, Sang X, Shen L. The effects of intermittent bolus paravertebral block on analgesia and recovery in open hepatectomy: a randomized, double-blinded, controlled study. BMC Surg. 2023 Aug 5;23(1):218. doi: 10.1186/s12893-023-02125-0.

    PubMed 37543575

Questions about this trial

What is this clinical trial studying?

A study testing Paravertebral block-ropivacaine and Paravertebral block-saline in people with Paravertebral Block and Hepatectomy, 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 18 Feb 2022. 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?

Postoperative 48hrs morphine (time frame: Postoperative 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04304274, which also lists 1 linked publication.

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 18 Feb 2022.

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