Rhomboid Intercostal and Sub-serratus Block

NCT04859803 | Completed Early Phase 1 DMC

• 1 other identifier: N-30-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhomboid Intercostal Block

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  Postoperative morphine consumption

  24 hours

Secondary Outcomes (3)

• recovery time

  1 hour

• Pain evaluation

  24 hous

• time to first analgesia

  24 hous

Study Arms (2)

RISS group

ACTIVE COMPARATOR

patients will receive rhomboid intercostal block under ultrasound guidance.

Procedure: Patients will be received rhomboid intercostal block under ultrasound guidance.

Control group

ACTIVE COMPARATOR

Patients will received the conventional intravenous analgesia

Drug: conventional intravenous analgesia

Interventions

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.

RISS group

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

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: June 1, 2021
• Primary Completion: September 25, 2023
• Study Completion: November 2, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

EG (1)