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Completed

NCT Number: NCT04859803

Rhomboid Intercostal and Sub-serratus Block

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients between 18-50 years. ASA physical status I and II Male gender

Exclusion criteria

Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV

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Treatment and study plan

Patients will be received rhomboid intercostal block under ultrasound guidance.

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.

Conventional intravenous analgesia

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

Primary outcomes

  1. morphine consumption

    Time frame: 24 hours

    Postoperative morphine consumption

Secondary outcomes

  1. recovery time

    Time frame: 1 hour

    The time from stopping anaesthetic agent until extubation

  2. Pain evaluation

    Time frame: 24 hous

    Pain evaluation using the visual analog scale score,, 0= pain , 10= sever pain

  3. time to first analgesia

    Time frame: 24 hous

    duration of block

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Efficacy of Rhomboid Intercostal Block With Sub-serratus Block on Perioperative Analgesia in Patients Undergoing Gynecomastia Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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