NCT05301075

Brief Summary

Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

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

March 19, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

March 19, 2022

Last Update Submit

March 19, 2022

Conditions

Rhomboid Intercostal Block

Outcome Measures

Primary Outcomes (1)

  • nalbuphine consumption i

    Postoperative nalbuphine consumption

    24 hours

Secondary Outcomes (2)

  • nalbuphine consumption.

    2 hours

  • Patient's satisfaction

    24 hours

Study Arms (2)

control group

SHAM COMPARATOR

patients will receive sham block.

Drug: Rhomboid Intercostal and Sub-Serratus block

RISS group

ACTIVE COMPARATOR

will receive Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance

Drug: Rhomboid Intercostal and Sub-Serratus block

Interventions

Rhomboid Intercostal and Sub-Serratus blockDRUG

Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance

RISS groupcontrol group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

March 21, 2022

Primary Completion

August 13, 2023

Study Completion

August 30, 2023

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

EG(1)