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NCT Number: NCT04304274

Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

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.

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Key information

Conditions

Paravertebral Block Agnosia Analgesia Hepatectomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Recovery Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 yrs
  • American Society of Anesthesiologists physical statusⅠ-Ⅲ
  • Undergo hepatectomy with J-shape subcostal incision
  • Informed consent

Exclusion criteria

  • 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

Treatment and study plan

Paravertebral block-ropivacaine

Procedure

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)

Other names: PVB group

Paravertebral block-saline

Procedure

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)

Other names: Control group

patient controlled analgesia with morphine

Drug

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

Other names: PCIA

Primary outcomes

  1. Postoperative 48hrs morphine

    Time frame: Postoperative 48 hours

    Cumulate morphine consumption 48 hours after hepatectomy

Secondary outcomes

  1. Heart rate

    Time frame: During the operation

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

  2. Mean blood pressure

    Time frame: During the operation

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

  3. Sevoflurane concentration

    Time frame: During the operation

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

  4. Intraoperative medication dose

    Time frame: During the operation

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

  5. Fluid volumes

    Time frame: During the operation

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

  6. Awake and extubation time

    Time frame: At the end of the operation

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

  7. Postoperative morphine consumption

    Time frame: Postoperative 2, 4, 12, 24hours

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

  8. Operation time

    Time frame: During the operation

    Time from the start to the end of the operation

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

    Time frame: Postoperative 0, 2, 4, 12, 24 and 48 hours

    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.

  10. Adverse effects

    Time frame: Postoperative 0-48 hours

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

  11. Rescue analgesia

    Time frame: Postoperative 0-48hours

    Times of rescue analgesia

  12. Postoperative recovery indices

    Time frame: Postoperative 48 hours

    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.

  13. Satisfaction indices

    Time frame: Postoperative 48 hours

    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.

  14. Length of hospital stay

    Time frame: Two weeks after hospital discharge

    Number of in-hospital days from admission to discharge

  15. Chronic recovery data

    Time frame: Postoperative 3 months

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

  16. Chronic pain characteristics

    Time frame: Postoperative 3 months

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

  17. Chronic pain NRS score

    Time frame: Postoperative 3 months

    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.

Sponsors and collaborators

Lead sponsor

Cui Xulei

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2020
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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