Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

NCT ID: NCT04304274

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2021-12-10

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

PTPVB-ropivacaine

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

Group Type: EXPERIMENTAL

Paravertebral block-ropivacaine

Intervention Type: 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)

patient controlled analgesia with morphine

Intervention Type: DRUG

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

PTPVB-saline

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

Group Type: PLACEBO_COMPARATOR

Paravertebral block-saline

Intervention Type: 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)

patient controlled analgesia with morphine

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

patient controlled analgesia with morphine

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

Intervention Type: DRUG

Other Intervention Names

PVB group; Control group; PCIA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cui Xulei

OTHER

Sponsor Role: lead

Responsible Party

Cui Xulei

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xulei Cui, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37543575 (View on PubMed)

Other Identifiers

PTPVB-H

Identifier Type: -

Identifier Source: org_study_id