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NCT Number: NCT03018899

Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paravertebral block

Procedure

Ultrasound guided two-segment paravertebral block

epidural anesthesia

Procedure

thoracic epidural anesthesia

Primary outcomes

  1. pain score 12h post operation

    Time frame: 12 hours postoperation

Secondary outcomes

  1. time spent to perform block

    Time frame: during block

  2. dose of intraoperative opioids

    Time frame: during operation

  3. rate of hypotension

    Time frame: during operation

  4. Muscle Power Grading of the lower legs at the end of the operation

    Time frame: 12 hours postoperation

  5. opioid consumption postoperation

    Time frame: 12 hours postoperation

  6. postoperative PONV score and the frequency of vomiting

    Time frame: 24 hours postoperation

  7. Hospitalization duration

    Time frame: 10 days postoperation

  8. Patient satisfaction

    Time frame: one day before discharge

    Patient satisfaction will be evaluated by 5-point Likert scal

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Acronym: PVB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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