NCT04304274

Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Cui Xulei · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Paravertebral Block
• Hepatectomy
• Analgesia
• Postoperative Recovery

Interventions

Type	Name	Description
PROCEDURE	Paravertebral block-ropivacaine	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)
PROCEDURE	Paravertebral block-saline	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)
DRUG	patient controlled analgesia with morphine	Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg

Timeline

• Start date: 2020-03-10
• Primary completion: 2021-06-10
• Completion: 2021-12-10
• First posted: 2020-03-11
• Last updated: 2022-02-18

Locations

1 site across 1 country: China