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Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy (PVB)

Primary Purpose

Kidney Calculi

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
paravertebral block
epidural anesthesia
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring paravertebral block, ultrasound, percutaneous nephrolithotomy, postoperative pain

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

paravertebral block

Epidural

Arm Description

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

patients received thoracic epidural anesthesia for percutaneous nephrolithotomy

Outcomes

Primary Outcome Measures

pain score 12h post operation

Secondary Outcome Measures

time spent to perform block
dose of intraoperative opioids
rate of hypotension
Muscle Power Grading of the lower legs at the end of the operation
opioid consumption postoperation
postoperative PONV score and the frequency of vomiting
Hospitalization duration
Patient satisfaction
Patient satisfaction will be evaluated by 5-point Likert scal

Full Information

First Posted
October 13, 2016
Last Updated
October 28, 2019
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03018899
Brief Title
Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy
Acronym
PVB
Official Title
Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
paravertebral block, ultrasound, percutaneous nephrolithotomy, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paravertebral block
Arm Type
Experimental
Arm Description
patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy
Arm Title
Epidural
Arm Type
Active Comparator
Arm Description
patients received thoracic epidural anesthesia for percutaneous nephrolithotomy
Intervention Type
Procedure
Intervention Name(s)
paravertebral block
Intervention Description
Ultrasound guided two-segment paravertebral block
Intervention Type
Procedure
Intervention Name(s)
epidural anesthesia
Intervention Description
thoracic epidural anesthesia
Primary Outcome Measure Information:
Title
pain score 12h post operation
Time Frame
12 hours postoperation
Secondary Outcome Measure Information:
Title
time spent to perform block
Time Frame
during block
Title
dose of intraoperative opioids
Time Frame
during operation
Title
rate of hypotension
Time Frame
during operation
Title
Muscle Power Grading of the lower legs at the end of the operation
Time Frame
12 hours postoperation
Title
opioid consumption postoperation
Time Frame
12 hours postoperation
Title
postoperative PONV score and the frequency of vomiting
Time Frame
24 hours postoperation
Title
Hospitalization duration
Time Frame
10 days postoperation
Title
Patient satisfaction
Description
Patient satisfaction will be evaluated by 5-point Likert scal
Time Frame
one day before discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Mei, Doctor
Organizational Affiliation
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For patient's privacy

Learn more about this trial

Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy

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