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Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

Primary Purpose

Renal Stone, Nephrolithiasis, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plain Block
Paravertebral Block
Sponsored by
Nazmy Edward Seif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Stone focused on measuring Erector spinae plain block, Paravertebral block, Ultrasound-guided, Percutaneous nephrolithotomy, Analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESPB group

PV group

Arm Description

Erector Spinae Plain Block

Paravertebral Block

Outcomes

Primary Outcome Measures

Morphine consumption.
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2021
Last Updated
July 18, 2022
Sponsor
Nazmy Edward Seif
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1. Study Identification

Unique Protocol Identification Number
NCT04998435
Brief Title
Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy
Official Title
Ultrasound-Guided Paravertebral Block Versus Erector Spinae Plain Block For Perioperative Analgesia In Adults Undergoing Percutaneous Nephrolithotomy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone, Nephrolithiasis, Analgesia, Anesthesia
Keywords
Erector spinae plain block, Paravertebral block, Ultrasound-guided, Percutaneous nephrolithotomy, Analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Active Comparator
Arm Description
Erector Spinae Plain Block
Arm Title
PV group
Arm Type
Active Comparator
Arm Description
Paravertebral Block
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plain Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Paravertebral Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine consumption.
Description
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef K Salama, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nazmy S Michael, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

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