Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

NCT04304274 | Completed

• 1 other identifier: PTPVB-H
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Paravertebral Block; Hepatectomy; Analgesia; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative 48hrs morphine

  Cumulate morphine consumption 48 hours after hepatectomy

  Postoperative 48 hours

Secondary Outcomes (17)

• Heart rate

  During the operation

• Mean blood pressure

  During the operation

• Sevoflurane concentration

  During the operation

• Intraoperative medication dose

  During the operation

• Fluid volumes

  During the operation

Study Arms (2)

PTPVB-ropivacaine

EXPERIMENTAL

Programmed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine

Procedure: Paravertebral block-ropivacaine; Drug: patient controlled analgesia with morphine

PTPVB-saline

PLACEBO COMPARATOR

Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine

Procedure: Paravertebral block-saline; Drug: patient controlled analgesia with morphine

Interventions

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)

Also known as: PVB group

PTPVB-ropivacaine

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)

Also known as: Control group

PTPVB-saline

patient controlled analgesia with morphine DRUG

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

Also known as: PCIA

PTPVB-ropivacaine; PTPVB-saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cui Xulei: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 37543575 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups; Analgesia, Patient-Controlled; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Analgesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Xulei Cui, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 11, 2020
• Study Start: March 10, 2020
• Primary Completion: June 10, 2021
• Study Completion: December 10, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

CN (1)