NCT07672600

Brief Summary

This study is planned as a single-center randomized single blinded study and includes patients undergoing percutaneous nephrolitotomy.The aim of the study is to evaluate the effect of ultrasound guided erector spinal plane block on postoperative analgesia in percutaneous nephrolitotomy. Primary outcome is the total 24 hour morphine consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 23, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

Erector spinae plane blockpercutaneous nephrolithotomypostoperative analgesiaregional anaesthesiamorphine

Outcome Measures

Primary Outcomes (1)

  • Total 24-hour morphine consumption

    Total 24-hour intravenous morphine consumption via patient controlled analgesia device

    24 hours

Secondary Outcomes (10)

  • Pain assessment

    24 hours

  • Additional analgesic requirement

    24 hours

  • Postoperative nausea and vomiting

    24 hours

  • Patient satisfaction

    Up to 24 hours

  • Surgeon satisfaction

    Up to 24 hours

  • +5 more secondary outcomes

Study Arms (2)

Group erector spinae plane block (Group ESPB)

ACTIVE COMPARATOR

Patients received erector spinae plane block for postoperative analgesia

Procedure: Erector Spinae Plane Block

Group Control (Group C)

ACTIVE COMPARATOR

Patients received only intravenous analgesia

Procedure: Intravenous analgesia

Interventions

Erector spinae plane block is applied in longitudinal plane at T9 level.

Group erector spinae plane block (Group ESPB)

Inravenous morphine is administered via patient controlled analgesia device.

Group Control (Group C)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective percutaneous nephrolitotomy
  • American Society of Anesthesiologists (ASA) physical status I-II

You may not qualify if:

  • Refusal to participate
  • Coagulopathy,
  • Infection at the block site
  • Allergy to local anaesthetics
  • Previous surgery in the block area
  • Severe systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Officials

  • Momunat Dadashova, MD

    Liv Hospital Vadi Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

October 1, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

July 8, 2026

Record last verified: 2026-06

Locations