Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Breast Cancer Surgeries
NCT06781346 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2025-01-17
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
Interventions
- PROCEDURE
-
Rhomboid Intercostal Block
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.
- PROCEDURE
-
Thoracic Paravertebral Block
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.
Sponsors & Collaborators
-
Fayoum University Hospital
lead OTHER
Principal Investigators
-
Mahdy A Abd El-hady, MD · Faculty of medicine, Fayoum university
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-15
- Primary Completion
- 2025-12-15
- Completion
- 2025-12-15
Countries
- Egypt
Study Locations
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