NCT06131151

Brief Summary

The aim of the study is to compare the post-operative analgesic effect of USG unilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for after percutaneous Nephrolithotomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing postoperative analgesia.

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Status
unknown

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

First Submitted

Initial submission to the registry

October 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

November 14, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 30, 2023

Last Update Submit

November 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The first call for rescue analgesia after the end of the surgery

    24 hours

Secondary Outcomes (1)

  • pain scores; Numerical Rating Scale (NRS)

    24 hours

Study Arms (2)

External Oblique Intercostal Block

EXPERIMENTAL

27 patients will receive External Oblique Intercostal Block. A volume of 20 ml of LA (20 ml of bupivacaine 0.375% plus 5 ug/ml adrenaline ) will be injected.

Other: Nerve block

Erector Spinae Plane Block

EXPERIMENTAL

27 patients will receive Erector Spinae Plane Block. A volume of 20 ml of LA (20 ml of bupivacaine 0.375% plus 5 ug/ml adrenaline ) will be injected.

Other: Nerve block

Interventions

Nerve block in percutaneous nephrolithotomy

Erector Spinae Plane BlockExternal Oblique Intercostal Block

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years Body mass index of 18-35 kg/m2 Patients with the American Society of Anesthesiologists physical status I/II Patients scheduled for elective Percutaneous Nephrolithotomy Both sexes, males and females

You may not qualify if:

  • Patients refusal Allergy to local anaesthetics Infection at the site of injection Coagulopathy Chronic pain syndrome Prolonged opioid medication Patients who received any analgesic 24 h befor surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Amr Thabet

    Department of anesthesia, intensive care and pain management

    STUDY DIRECTOR

Central Study Contacts

Rehab Gomaa, master

CONTACT

Amr Thabet, co-auther

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 14, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 14, 2023

Record last verified: 2023-10