U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block

NCT06274814 | Completed

• 1 other identifier: AP23.501.038
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.

Conditions

Breast Neoplasm Female; Analgesics

Keywords

Analgesics; Opioids; Breast Neoplasms; Postoperative Pain; Mastectomy; Nerve block; Breast Cancer Surgery

Outcome Measures

Primary Outcomes (2)

• Total morphine consumption

  Visual Analog scale ≥6 using opioid (3mg morphine) VAS score is from 0 to 10 as 0 is no pain and 10 the wariest pain can ever experience

  24 hours

• Visual Analog scale score postoperative

  Visual Analog scale≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine) (0 mean no pain - 10 mean worset pain ever)

  24 hours

Secondary Outcomes (3)

• Intraoperative fentanyl consumption

  intraoperative

• Heart rate intraoperative

  intraoperative

• Timing of first rescue analgesia

  24 hours

Study Arms (3)

Type 2 Pectoral Nerve Block

ACTIVE COMPARATOR

23 patients Type 2 Pectoral Nerve Block pecs2 Group A

Procedure: U/S guided Type 2 Pectoral Nerve Block

RISS Rhomboid intercostal block combined with the sub-serratus plane block

ACTIVE COMPARATOR

23 patients the RIB combined with the sub-serratus plane block (RISS) Group B

Procedure: U/S guided RIB combined with the sub-serratus plane block (RISS)

No block intervention

NO INTERVENTION

routine IV analgesia 23 patients no block intervention was performed. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. Group C

Interventions

U/S guided Type 2 Pectoral Nerve Block PROCEDURE

20 mL separates the pectoralis major and minor muscles, while 10 mL separates the serratus and pectoralis major muscles

Type 2 Pectoral Nerve Block

U/S guided RIB combined with the sub-serratus plane block (RISS) PROCEDURE

he ipsilateral arm was abducted. RISS was performed. Using a 6-13 MHz linear ultrasound probe was placed medial to the medial border of the scapula in the oblique sagittal plane.. A 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was 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. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected.

RISS Rhomboid intercostal block combined with the sub-serratus plane block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients.
• Scheduled for unilateral conservative mastectomy.
• Age 18-65 years.
• American Society of Anesthesiologists (ASA) physical status I- II.

You may not qualify if:

• Patient refusal.
• Coagulation disorders.
• Body mass index \> 40 kg/m2.
• Uncooperative or psychiatric patients.
• Infection at the injection site.
• Patients with a history of allergy to local anesthetics.
• Patients with a history of treatment for chronic pain.
• Previous history of breast surgery or other chest surgery.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National cancer Insititute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• ahmed soliman

  National Cancer Institute Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: June 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)