Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

Cui Xulei

Status: Completed

Conditions: Postoperative Recovery; Hepatectomy; Analgesia; Paravertebral Block

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04304274

PTPVB-H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

PTPVB-ropivacaine

Experimental group

Description:

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

Treatment:

Drug: patient controlled analgesia with morphine

Procedure: Paravertebral block-ropivacaine

PTPVB-saline

Placebo Comparator group

Description:

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

Treatment:

Drug: patient controlled analgesia with morphine

Procedure: Paravertebral block-saline