Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy

Kidney Calculi Clinical Trial

— PVB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018899
• Other study ID #: PVB-TJ
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2019
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status?-?

• 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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Intervention

Procedure:
• paravertebral block
Ultrasound guided two-segment paravertebral block
• epidural anesthesia
thoracic epidural anesthesia

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

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