Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

July 18, 2022 updated by: Nazmy Edward Seif

Ultrasound-Guided Paravertebral Block Versus Erector Spinae Plain Block For Perioperative Analgesia In Adults Undergoing Percutaneous Nephrolithotomy: A Randomized Clinical Trial

Nowadays, Percutaneous Nephrolithotomy (PCNL) has been the surgical procedure of choice for renal stones larger than 2cm or staghorn stones. Yet, the associated postoperative pain is a major drawback. The regional anesthetic management of pain in PCNL operation has been of great concern. The introduction of ultrasound guided erector spinae plane block and paravertebral plane block has been under great focus regarding the efficacy of postoperative pain management. Paravertebral plane block (PVB) is a regional nerve block technique that depends on local anesthetic injection adjacent to the vertebra to block spinal nerve roots in a dermatomal distribution. Erector spinae plane block (ESPB) is a newer regional anesthesia technique that depends on injecting local anesthetic (LA) in a plane between the transverse process and erector spinae muscle. The LA diffuses into the paravertebral space and spreads on both rami (dorsal and ventral) of spinal nerves through spaces between adjoining vertebrae.

The aim of this study is to compare the effect of ultrasound guided Paravertebral blockade versus Erector spinae blockade on postoperative opioid use as well as postoperative pain control in patients undergoing unilateral PCNL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I - II.
  • Patients undergoing unilateral percutaneous nephrolithotomy (PCNL) surgery under general anesthesia.

Exclusion Criteria:

  • Patient refusal.
  • Uncooperative patients.
  • Allergy to local anesthetics.
  • Infection or anatomical abnormality at injection site.
  • Coagulopathy.
  • Bilateral PCNL.
  • Spinal anesthesia or any other regional anesthesia.
  • Block failure: the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESPB group
Erector Spinae Plain Block
Procedure: Erector Spinae Plain Block

Using aseptic technique, ultrasound-guided ESPB will be performed with the patient in sitting position. The spinous process of the vertebra and a point 3 cm lateral to it will be marked before performing the block. The needle will be inserted and advanced under sono-visualization to contact the transverse process of the vertebra. After negative aspiration, LA will be deposited into the fascial plane deep to erector spinae muscle.

30 ml of Bupivacaine 0.25% will be used as LA, injected using a 22-gauge spinal needle at the level of T10 which will be identified by counting 3 spinous processes below T7 which is at the level of the inferior angle of the scapula and also rechecked by counting down from C7.

Patients will then receive general anesthesia. All patients will receive paracetamol (1gm/8hrs IV) as a regular analgesia. IV morphine (0.02mg/kg) will be given as a rescue analgesia if the Visual Analogue Scale for pain is ≥ 4.
Active Comparator: PV group
Paravertebral Block
Procedure: Paravertebral Block

Using sterile technique, ultrasound scanning of thoracic paravertebral space will be done in sitting position. The transverse process will be identified as hyperechoic structure while pleura will be identified as a mobile hypoechoic structure. The needle will be inserted cranio-caudal and advanced under sono-visualization to the identified thoracic paravertebral space. After negative aspiration, LA will be deposited displacing the pleura.

30 ml of Bupivacaine 0.25% will be used as LA, injected using a 22-gauge spinal needle at the level of T10 which will be identified by counting 3 spinous processes below T7 which is at the level of the inferior angle of the scapula and also rechecked by counting down from C7.

Patients will then receive general anesthesia. All patients will receive paracetamol (1gm/8hrs IV) as a regular analgesia. IV morphine (0.02mg/kg) will be given as a rescue analgesia if the Visual Analogue Scale for pain is ≥ 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption.
Time Frame: 24 hours
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazmy Edward Seif

Investigators

  • Study Director: Atef K Salama, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.
  • Study Chair: Nazmy S Michael, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVBVESPBPCNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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