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NCT Number: NCT04998435

Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Renal Stone Agnosia Analgesia Anesthesia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erector Spinae Plain Block

Procedure

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.

paravertebral block

Procedure

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 outcomes

  1. Morphine consumption.

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Nazmy Edward Seif

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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