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Clinical Trials/NCT04998435
NCT04998435CompletedNot Applicable

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

Nazmy Edward Seif1 site in 1 country50 target enrollmentStarted: August 11, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Morphine consumption.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

ESPB group

Active Comparator

Erector Spinae Plain Block

Intervention: Erector Spinae Plain Block (Procedure)

PV group

Active Comparator

Paravertebral Block

Intervention: Paravertebral Block (Procedure)

Outcomes

Primary Outcomes

Morphine consumption.

Time Frame: 24 hours

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nazmy Edward Seif
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Nazmy Edward Seif

Clinical Professor

Cairo University

Study Sites (1)

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