Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

NCT04998435 | Completed

• 1 other identifier: PVBVESPBPCNL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Stone; Nephrolithiasis; Analgesia; Anesthesia

Keywords

Erector spinae plain block; Paravertebral block; Ultrasound-guided; Percutaneous nephrolithotomy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine consumption.

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

  24 hours

Study Arms (2)

ESPB group

ACTIVE COMPARATOR

Erector Spinae Plain Block

Procedure: Erector Spinae Plain Block

PV group

ACTIVE COMPARATOR

Paravertebral Block

Procedure: Paravertebral Block

Interventions

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.

ESPB group

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.

PV group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis; Agnosia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Atef K Salama, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.

  STUDY DIRECTOR

• Nazmy S Michael, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 10, 2021
• Study Start: August 11, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

EG (1)