Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

NCT ID: NCT05661279

Last Updated: 2023-09-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2023-10-30

Brief Summary

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evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

Detailed Description

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* To assess and compare quality of post- operative analgesia in each group.
* Time of performance of block in both groups.
* To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group C:

control group who will be given general anesthesia only

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

general anesthesia

Group R:

Rhomboid intercostal block then general anesthesia

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

general anesthesia

general anesthesia plus Rhomboid intercostal block

Intervention Type PROCEDURE

the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia

group S

Serratus anterior plane block then general anesthesia

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

general anesthesia

Serratus anterior plane block

Intervention Type PROCEDURE

The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia

Interventions

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general anesthesia

general anesthesia

Intervention Type PROCEDURE

general anesthesia plus Rhomboid intercostal block

the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia

Intervention Type PROCEDURE

Serratus anterior plane block

The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged between 21 to 60 years
* Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
* Informed consents
* ASA I \& II
* Body mass index 25-30 kg/m2.

Exclusion Criteria

* patients on anti-platelet, anticoagulant or B blocker drugs
* Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
* history of allergy to local anesthesia or opioid analgesia,
* pregnancy.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Heba M Fathi

prof/Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba M Fathi

Role: PRINCIPAL_INVESTIGATOR

faculty of human medicine ,zagazig university

Locations

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Heba M Fathi

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Heba M Fathi, M.D

Role: CONTACT

01000143938

Facility Contacts

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Heba M Fathi, M.D

Role: primary

Other Identifiers

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zu-IRB # 10060

Identifier Type: -

Identifier Source: org_study_id

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