NCT06778707

Brief Summary

The aim of the study is to compare the analgesic efficacy of external oblique intercostal block vs subcostal transversus abdominis plane block in patients undergoing open nephrectomy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

January 5, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 10, 2025

Last Update Submit

January 15, 2025

Conditions

Keywords

External Oblique Intercostal BlockSubcostal Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption in the first postoperative 24 hour

    Total morphine consumption in the first postoperative 24 hour

    first postoperative 24 hour

Secondary Outcomes (2)

  • NRS when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour

    when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour

  • Total intraoperative fentanyl consumption with exclusion of fentanyl used in induction

    intraoperative

Study Arms (2)

group E

ACTIVE COMPARATOR

This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles. After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

Procedure: External Oblique Intercostal Block

group T

ACTIVE COMPARATOR

Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

Procedure: Subcostal Transversus Abdominis Plane Block

Interventions

In group E, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

group E

In group T, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

group T

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who will be included in the study age from 21 to 60 years, both male and female, with American Society of Anesthesiologists (ASA) Physical Status Classification System I-III.

You may not qualify if:

  • Any patient refuses to participate, has bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases, on chronic opioid use, with history of allergy to local anesthetics and has infection at the needle entry point will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, 1234, Egypt

Location

Related Publications (1)

  • 1.Bansal P, Sultania N, Mittal T. External oblique intercostal block in open nephrectomy patients-A zenith in analgesia for anterolateral upper abdominal surgeries: A case series. Asian Journal of Medical Sciences. 2024;15(2):264-8.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed A Abdelwahed, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded prospective
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at anesthesia & surgical ICU & Pain Medicine

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 16, 2025

Study Start

January 5, 2025

Primary Completion

June 30, 2025

Study Completion

August 20, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

sharing abstract and final paper on a medical journal

Shared Documents
STUDY PROTOCOL
Time Frame
data will be available after finishing the study within one year
Access Criteria
google scholar

Locations