Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy

NCT ID: NCT03018899

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-31

Brief Summary

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This prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to epidural block.

Detailed Description

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Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or neuraxial anesthesia. The investigators have reported three patients who were at high risk of both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with ultrasound guided paravertebral block. Then,The investigators performed ultrasound guided paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully. The investigators' impression is that paravertebral block is as effective as epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

Objectives:To assess the efficacy and safety of paravertebral block compared to epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The primary outcome will be the pain score 12h postoperation. The secondary outcomes will include: time spent to perform block, dose of intraoperative opioids, rate of hypotension need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and the frequency of vomiting , hospitalization duration and patient satisfaction.

Clinical Implications: Ultrasound guided paravertebral block could be an equally effective and safe alternative to epidural block for surgical anesthesia of percutaneous nephrolithotomy.

Conditions

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Kidney Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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paravertebral block

patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy

Group Type EXPERIMENTAL

paravertebral block

Intervention Type PROCEDURE

Ultrasound guided two-segment paravertebral block

Epidural

patients received thoracic epidural anesthesia for percutaneous nephrolithotomy

Group Type ACTIVE_COMPARATOR

epidural anesthesia

Intervention Type PROCEDURE

thoracic epidural anesthesia

Interventions

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paravertebral block

Ultrasound guided two-segment paravertebral block

Intervention Type PROCEDURE

epidural anesthesia

thoracic epidural anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo first stage percutaneous nephrolithotomy
* Informed consent

Exclusion Criteria

* BMI\>35
* Coagulopathy, on anticoagulants
* History of surgery on spine
* Spine deformity
* A known allergy to the drugs being used
* Tumor or infection at the site of puncture
* inability to provide adequate informed consent
* refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Wei Mei

Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Mei, Doctor

Role: STUDY_DIRECTOR

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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PVB-TJ

Identifier Type: -

Identifier Source: org_study_id

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