NCT06935006

Brief Summary

50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

March 9, 2025

Last Update Submit

April 11, 2025

Conditions

Percutaneous Nephrolithotomy (PCNL)

Outcome Measures

Primary Outcomes (1)

  • Reduction of postoperative pain

    VAS score for pain measurement

    1 year

Study Arms (2)

Erector spinae plane block group

ACTIVE COMPARATOR
Procedure: Sonographic guided Erector spinae plane block

Conventional analgesia group

ACTIVE COMPARATOR
Drug: Intravenous opioid

Interventions

Sonographic guided Erector spinae plane blockPROCEDURE

Ultrasound guided plane block using 20 ml of 0.25% bupivacaine at the level of transverse process of T8

Erector spinae plane block group
Intravenous opioidDRUG

0.1 mg/kg morphine intravenous pre operative

Conventional analgesia group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1 to ASA 2 18 to 60 years

You may not qualify if:

  • patient refusal Significant neurological , psychiatric or neuromascular disease Drug abuse Pregnant or lactating women Suspected coagulopathy Morbid obesity Known allergy to some medications Septicaemia and local infection at block site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ahmed Mahmoud Azmy, Assistant lecturer

CONTACT

01004793896ahmedazmy19692@yahoo.com

Fawzy Abbas, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Anaethesia and intensive care unit

Study Record Dates

First Submitted

March 9, 2025

First Posted

April 18, 2025

Study Start

May 1, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

April 18, 2025

Record last verified: 2025-04