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Clinical Trials/NCT03018899
NCT03018899
Completed
Not Applicable

Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy

Huazhong University of Science and Technology1 site in 1 country50 target enrollmentSeptember 2016
ConditionsKidney Calculi

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Calculi
Sponsor
Huazhong University of Science and Technology
Enrollment
50
Locations
1
Primary Endpoint
pain score 12h post operation
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
July 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Mei

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

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

pain score 12h post operation

Time Frame: 12 hours postoperation

Secondary Outcomes

  • dose of intraoperative opioids(during operation)
  • time spent to perform block(during block)
  • rate of hypotension(during operation)
  • opioid consumption postoperation(12 hours postoperation)
  • postoperative PONV score and the frequency of vomiting(24 hours postoperation)
  • Hospitalization duration(10 days postoperation)
  • Muscle Power Grading of the lower legs at the end of the operation(12 hours postoperation)
  • Patient satisfaction(one day before discharge)

Study Sites (1)

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