Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy (PVB)

Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of 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.

Study Overview

• Status: Completed
• Conditions: Kidney Calculi
• Intervention / Treatment: Procedure: paravertebral block; Procedure: epidural anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: paravertebral block; patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy	Procedure: paravertebral block; Ultrasound guided two-segment paravertebral block
Active Comparator: Epidural; patients received thoracic epidural anesthesia for percutaneous nephrolithotomy	Procedure: epidural anesthesia; thoracic epidural anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain score 12h post operation	12 hours postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time spent to perform block		during block
dose of intraoperative opioids		during operation
rate of hypotension		during operation
Muscle Power Grading of the lower legs at the end of the operation		12 hours postoperation
opioid consumption postoperation		12 hours postoperation
postoperative PONV score and the frequency of vomiting		24 hours postoperation
Hospitalization duration		10 days postoperation
Patient satisfaction	Patient satisfaction will be evaluated by 5-point Likert scal	one day before discharge

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Wei Mei, Doctor, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; postoperative pain; percutaneous nephrolithotomy; paravertebral block
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: PVB-TJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: For patient's privacy