Erector Spinae Plane Block Versus Retrolaminar Block for Analgesia in Percutaneous Nephrolithotomy

NCT06710444 | Completed DMC

• 1 other identifier: 0306627
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the effects of ultrasound-guided ESPB and RLB on intraoperative and postoperative analgesia in patients undergoing PCNL to identify a safe and effective regional block method for postoperative analgesia

Conditions

Postoperative Analgesia; Pain Management; PCNL; Regional Anesthesia Block

Keywords

Postoperative; Analgesia; Pain; Erector Spinae; Retrolaminar; Block; PCNL

Outcome Measures

Primary Outcomes (1)

• measurement of visual analogue score

  measurement of visual analogue score during rest and movement. The Score range from 0-10. 0 means no pain and 10 indicates the worst pain ever

  after the surgery average 48 hours postoperative

Secondary Outcomes (4)

• postoperative additional analgesic requirement

  after the surgery average 48 hours postoperative

• assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS)

  after the surgery average 48 hours postoperative

• Time to ambulate

  after the surgery average 12 hours postoperative

• presence of postoperative nausea and vomiting

  after the surgery average 48 hours postoperative

Study Arms (2)

Group I

ACTIVE COMPARATOR

This group will receive ultrasound-guided erector spinae plane block

Procedure: ultrasound-guided erector spinae plane block

Group II

EXPERIMENTAL

This group will receive ultrasound-guided Retrolaminar plane block

Procedure: ultrasound-guided retrolaminar plane block

Interventions

ultrasound-guided erector spinae plane block PROCEDURE

ESPB

Group I

ultrasound-guided retrolaminar plane block PROCEDURE

RLB

Group II

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients scheduled for PCNL

You may not qualify if:

• daily consumption of analgesics
• allergy to local anesthetics
• liver dysfunction
• infection or previous surgery in the vertebral region.
• patient refusal
• pregnancy

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ahmed S.Shehab

Alexandria, 21431, Egypt

Location

Related Publications (1)

• Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.

  PMID: 32915300 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain; Bites and Stings

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Ahmed S. Shehab, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Anaesthesia and Surgical ICU department

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study ends upon request
• Access Criteria: Accessible through the web site

Locations

EG (1)