Clinical trial NCT03018899: Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy
Official title: Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Keywords: paravertebral block
ultrasound
percutaneous nephrolithotomy
postoperative pain
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain score 12h post operation
timeFrame: 12 hours postoperation
Secondary outcomes:
measure: time spent to perform block
timeFrame: during block
measure: dose of intraoperative opioids
timeFrame: during operation
measure: rate of hypotension
timeFrame: during operation
measure: Muscle Power Grading of the lower legs at the end of the operation
timeFrame: 12 hours postoperation
measure: opioid consumption postoperation
timeFrame: 12 hours postoperation
measure: postoperative PONV score and the frequency of vomiting
timeFrame: 24 hours postoperation
measure: Hospitalization duration
timeFrame: 10 days postoperation
measure: Patient satisfaction
timeFrame: one day before discharge
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Wei Mei, Doctor
role: STUDY_DIRECTOR
References: