Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy

NCT03018899 | Completed

• 1 other identifier: PVB-TJ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi

Keywords

paravertebral block; ultrasound; percutaneous nephrolithotomy; postoperative pain

Outcome Measures

Primary Outcomes (1)

• pain score 12h post operation

  12 hours postoperation

Secondary Outcomes (8)

• 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

Study Arms (2)

paravertebral block

EXPERIMENTAL

patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy

Procedure: paravertebral block

Epidural

ACTIVE COMPARATOR

patients received thoracic epidural anesthesia for percutaneous nephrolithotomy

Procedure: epidural anesthesia

Interventions

paravertebral block PROCEDURE

Ultrasound guided two-segment paravertebral block

paravertebral block

epidural anesthesia PROCEDURE

thoracic epidural anesthesia

Epidural

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Wei Mei, Doctor

  Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: January 12, 2017
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)