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

May 9, 2025 updated by: Ahmed Shehab, MD, Alexandria University

Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All the patients will be blinded to the intervention received in this study. All patients will receive standard general anesthesia technique with endotracheal intubation and muscle paralysis. Postoperatively, all patients will receive analgesia in the form of non-steroidal anti-inflammatory drugs and paracetamol. In case the VAS scores exceeded 4 in any group, the patients will receive rescue analgesia with 25 mg IV meperidine. In both groups, the ESPB and RLB will be performed after induction of general anesthesia using portable ultrasound device.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21431
        • Ahmed S.Shehab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients scheduled for PCNL

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
This group will receive ultrasound-guided erector spinae plane block
Procedure: ultrasound-guided erector spinae plane block
ESPB
Experimental: Group II
This group will receive ultrasound-guided Retrolaminar plane block
Procedure: ultrasound-guided retrolaminar plane block
RLB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of visual analogue score
Time Frame: after the surgery average 48 hours postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative additional analgesic requirement
Time Frame: after the surgery average 48 hours postoperative
Total cumulative analgesic requirement dose
after the surgery average 48 hours postoperative
assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS)
Time Frame: after the surgery average 48 hours postoperative
from 0 to 28, where 0 is so dissatisfied and 28 means very satisfied
after the surgery average 48 hours postoperative
Time to ambulate
Time Frame: after the surgery average 12 hours postoperative
Time from discharge from the operating theatre to start to ambulate
after the surgery average 12 hours postoperative
presence of postoperative nausea and vomiting
Time Frame: after the surgery average 48 hours postoperative
Number of postoperative nausea and vomiting
after the surgery average 48 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Ahmed S. Shehab, MD, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0306627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers

IPD Sharing Time Frame

After study ends upon request

IPD Sharing Access Criteria

Accessible through the web site

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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