Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Breast Cancer Surgeries

NCT06781346 | Not Yet Recruiting

• 1 other identifier: M 729
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a significant problem following breast surgery . If not treated in time, it may lead to delayed wound healing, respiratory depression, hemodynamic disorders, anxiety,other complications, and finally lead to difficult recovery of patients . Therefore, the prevention of postoperative pain is of great importance for patients. Opioids, while effective in pain management, are linked to a spectrum of adverse effects, including respiratory depression, post-operative nausea and vomiting, pruritus and constipation. The adoption of multimodal analgesia following breast cancer surgery emerges as a pivotal strategy to mitigate the complications associated with opioid use in the postoperative period.\[4\] US-guided rhomboid intercostal block (US-RIB) is a new fascial block technique discovered by Elsharkawy et al in 2016. Injection of local anaesthetic into the fascial plane between rhomboid major and intercostal muscles provided analgesia for both the anterior and posterior hemithorax,targets the lateral cutaneous branches of the ventral rami of the thoracic intercostal nerves from T2 to T9. Some clinical studies have reported that RIB can effectively reduce postoperative pain, reduce opioid consumption and improve the quality of recovery in patients with breast cancer surgeries . The ultrasound guided Thoracic paravertebral (TPV) block in the context of breast cancer surgery has been reported to decrease postoperative pain score up to 72 hours, reduce opioid consumption, improve the quality of recovery, and suppress the development or decrease the severity of chronic pain by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL). In our study investigators hypothesized that the Rhomboid Intercostal block (RIB) can provide an effective analgesia comparable with thoracic paravertebral (TPV) block without the necessity to approach the pleura and the attendant risks in adult patients undergoing Breast cancer surgeries.

Conditions

Pain, Postoperative

Keywords

Rhomboid Intercostal block; Breast surgery

Outcome Measures

Primary Outcomes (1)

• The total postoperative fentanyl consumption in the first 24 hours. (μg)

  The total postoperative fentanyl consumption in the first 24 hours. (μg)

  in the first 24 hours.

Secondary Outcomes (8)

• Total intraoperative fentanyl

  Intraoperative

• Blood pressure

  24 hours postoperative

• Time to first analgesic request

  24 hours postoperative

• VAS score

  24 hours postoperative

• Complications related to the block : pleural puncture , vascular puncture and local anesthesia systemic toxicity.

  Intraoperative

Study Arms (2)

Rhomboid intercostal block

EXPERIMENTAL

A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique.

Procedure: Rhomboid Intercostal Block

Thoracic paravertebral block

ACTIVE COMPARATOR

the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space.

Procedure: Thoracic Paravertebral Block

Interventions

Rhomboid Intercostal Block PROCEDURE

In RI block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle.

Rhomboid intercostal block

Thoracic Paravertebral Block PROCEDURE

In the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards.

Thoracic paravertebral block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older .
• American Society of Anesthesiologists (ASA) II-lll Scheduled for elective breast surgery for modified radical mastectomy, simple mastectomy, breast conservative surgery.

You may not qualify if:

• Patient refusal.
• Significant renal, hepatic and cardiovascular diseases.
• History of allergy to one of the study drugs.
• Any contraindication to regional anesthesia such as local infection or bleeding disorders.
• Chronic opioid use, history of chronic pain and cognitive disorders.
• Emergent surgeries

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum university Hospital

El Fayoum Qesm, Faiyum Gove, 63514, Egypt

Location

Related Publications (5)

• Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.

  PMID: 27291611 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.

  PMID: 30553225 BACKGROUND

• Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.

  PMID: 31176954 BACKGROUND

• Tulgar S, Kiziltunc B, Thomas DT, Manukyan MN, Ozer Z. The combination of modified pectoral nerves block and rhomboid intercostal block provides surgical anesthesia in breast surgery. J Clin Anesth. 2019 Dec;58:44. doi: 10.1016/j.jclinane.2019.04.040. Epub 2019 May 7. No abstract available.

  PMID: 31075623 BACKGROUND

• Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.

  PMID: 26431130 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mahdy A Abd El-hady, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed S Abdalla, Bch

CONTACT

1069491684; asa43@fayoum.edu.eg

Mahdy A Abd El-hady, MD

CONTACT

120 363 2563; maa45@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesiology

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 17, 2025
• Study Start: February 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)