NCT06048744

Brief Summary

The patients will be randomly allocated into two equal groups using a computer program. Group A: will receive U S guided external oblique intercostal block after induction. Group B: Patients will receive US guided erector spine block after induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

September 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

September 11, 2023

Last Update Submit

January 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • time for first rescue analgesia

    hours

    day 0

Secondary Outcomes (2)

  • visual analogue score VAS score

    24 hours

  • the number of rescue analgesics

    24hours

Study Arms (2)

external oblique intercostal block

ACTIVE COMPARATOR

After induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted. A 14-15 MHz linear ultrasound transducer (Sono-Site) was placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 30 ml of bupivacaine 0.25% will be administered incrementally. The drug will be injected after a negative aspiration into the plane deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles.

Procedure: external oblique intercostal block

Erector Spine Block

ACTIVE COMPARATOR

After induction of general anesthesia, patients will be positioned in the lateral position . A linear ultrasound transducer will be placed on the midline to identify the T8 spinous process. From this position, the ultrasound transducer was moved 2-3 cm laterally to visualize the hyperechoic line of the T8 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. 30 ml 0.25% bupivacaine will be injected.

Procedure: Erector Spine block

Interventions

U S guided external oblique intercostal block after induction.

external oblique intercostal block

US guided erector spine block after induction

Erector Spine Block

Eligibility Criteria

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

You may qualify if:

  • Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I\& II\&III scheduled for elective (Subcostal) Nephrectomy

You may not qualify if:

  • Patients who are:
  • Uncooperative.
  • Having allergy to any of the study drugs.
  • Known abuse of alcohol or medication.
  • Having Local infection at the site of injection or systemic infection.
  • Pregnancy.
  • With coagulation disorders or on anticoagulation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia university

Cairo, Shibin Elkom, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • AMAL G SAFAN, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaethesia

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

December 20, 2023

Study Completion

January 25, 2024

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations