Rhomboid Intercostal and Sub-serratus Block

NCT ID: NCT04859803

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-11-02

Brief Summary

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The rhomboid intercostal block (RIB) can provide good analgesia effects after thoracic surgery . The ultrasound-guided RIB is novel analgesic techniques recently described by Elsharkawy et al. . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia. However, the analgesic effects of the RISS block after breast surgery have not been analyzed through a randomized-controlled trial.

Detailed Description

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Conditions

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Rhomboid Intercostal Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers
double

Study Groups

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RISS group

patients will receive rhomboid intercostal block under ultrasound guidance.

Group Type ACTIVE_COMPARATOR

Patients will be received rhomboid intercostal block under ultrasound guidance.

Intervention Type PROCEDURE

Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously \[8\]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH \& Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.

Control group

Patients will received the conventional intravenous analgesia

Group Type ACTIVE_COMPARATOR

conventional intravenous analgesia

Intervention Type DRUG

Following endotracheal intubation, patients will be received morphine sulfate (0.02 mg/kg) bolus doses were used to preserve MAP and HR within 20% of pre-induction readings

Interventions

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Patients will be received rhomboid intercostal block under ultrasound guidance.

Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously \[8\]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH \& Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.

Intervention Type PROCEDURE

conventional intravenous analgesia

Following endotracheal intubation, patients will be received morphine sulfate (0.02 mg/kg) bolus doses were used to preserve MAP and HR within 20% of pre-induction readings

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Samir Wahdan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Cairo University.

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-30-2021

Identifier Type: -

Identifier Source: org_study_id