Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Respiratory Insufficiency

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Respiration Disorders

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Bupivacaine

After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle.

No block procedures will be performed in this group.

RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.

RIB+SAP blocks

Bakiye Uğur, MD

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.

The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.

Prospective, randomized, controlled study

The patients will be under general anesthesia and will not know if they received a block procedure or not.

The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups.

The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions

The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery

FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

The pain scores of the patients in the block group will be lower than the patients in the control group at the postoperative second hour.

The opioid consumption of the patients in the block group will be lower than the patients in the control group at the postoperative 24th hour.

FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

FEV1/FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

FEF25-75 values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

Muğla Sıtkı Koçman University

Associated Prof Dr

Analgesics

Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane.

Patients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.

rhomboid intercostal block

serratus anterior plane block

yahya m wahba, assist prof.

nevert a abdel ghaffar, assist prof

Tamer E abdallah, assist prof

Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax . Recently , fascial plane blocks have been introduced as an alternative such as erector spinae plane block and serratus plane block Serratus plane block were introduced by Blanco et al where local anesthetic injected superficial to the muscle to provide nerve block of the lateral cutaneous branches of the intercostal nerves Rhomboid intercostal block is an interfascial plane block for chest wall analgesia, it was reported in 2016 as alternative to thoracic epidural and paravertebral blocks.

This double blinded randomized(closed envelope technique) study will be conducted on eighty ASA I and II female patients aged between 20-60 years, undergoing modified radical mastectomy surgeries at Oncology Center Mansoura University (OCMU). The study will start at September 2022 and the recruitment will take approximately five months. The study duration can take about eight months. All patients undergoing general anesthesia. Informed consent will be taken after approval by the local ethics committee. The exclusion criteria included local skin infection , bleeding disorder ,coagulation abnormality ,spine or chest deformity , psychiatric disease, pregnancy and patients with allergy to any of the drug used .

Patients will be randomly assigned to either two groups according to the block used either rhomboid plane block in group R (n=30) received total volume of 20 ml of bupivacain 0.25% or serratus plane block group S (n=30) received total volume of 20 ml of bupivacaine 0.5% . The observer anesthetist and the surgeon were blinded to the solution. Operation will be performed by the same surgeon .Anesthetic management will be standardized and all patients will be premedicated with diazepam 5mg per orally at the morning of the surgery. Induction will be started with preoxygenation for 3 min, anesthesia will be induced with fentanyl (2ug/kg), 2 mg/kg propofol, muscle relaxation will be achieved by atracurium 0.05 mg kg and tracheal intubation will be achieved using suitable size of endotracheal tube . Anesthesia will be maintained with minimum alveolar concentration(MAC ) of isoflurane with air - oxygen and fentanyl 1µg/kg boluses and atracurium 0.2 mg/kg to maintain heart rate and pressure within 20% of their baseline values, the patients' lungs will be ventilated to maintain an ETCO2 of 30-35 mmHg. . Isoflurane will be discontinued at the start of skin closure, residual neuromuscular block will be antagonized with neostigmine 0.05 mg kg and atropine 0.025 mg kg and the trachea will be extubated. Heart rate ,end-tidal CO2, pulse oximetry and systolic blood pressure and diastolic blood pressure will be recorded before induction of anesthesia (baseline) and after induction of anesthesia then every 5min during surgery till end of surgery .

Post operative assessment:

In the PACU , patients were monitored for heart rate ,oxygen saturation ,systolic blood pressure and diastolic blood pressure for 1 hour postoperative by another anesthetist who was not aware of the study protocol . Patients were discharged to the surgical ward if they achieved score of 10 at modified Aldrete score .

Postoperative severity of pain which was assessed using VAS 1/2 hour after surgery, then at 1h, 2h, 4h, 6 h, 8h,12h and 24 h postoperatively . All patients were given IV ketorolac 30 mg/8 hour postoperatively and IV fentanyl 0.5µg/kg was available as rescue analgesia whenever VAS continued to be\>40 mm after 30 min of ketorolac injection. Fentanyl injection could be repeated. The time for the first postoperative analgesic dose requirements and the total dose of 24hour postoperative fentanyl consumption were recorded . Postoperative nausea and vomiting (PONV) were assessed using a four-point numerical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once), postoperative adverse effects and complications were recorded .

Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery

Mansoura University

assist. prof. of anesthesia and pain management

Rare Diseases

Neuralgia

Chronic Pain

Acute Pain

Peripheral Nervous System Diseases

Neuromuscular Diseases

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 30 ml of bupivacaine 0.25%.

No block procedure will be performed in this group.

After endotracheal intubation, patients will be positioned in lateral decubitus position. A RIB will be performed at the level of T5-T6 by ultrasound guidance. A single shot block will be performed by injecting 30 ml of 0.25% bupivacaine to the interfacial plane between rhomboid major muscle and intercostal muscle.

BAŞAK ALTIPARMAK, Ass Prof

BAŞAK ALTIPARMAK, ASSPROF

BAKİYE UĞUR

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. RIB has been reported to be successful in attenuating acute pain following breast surgeries. However, it's effect on chronic pain has not been evaluated yet. The primary hypothesis of the study is that the incidence of chronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 3rd month. The secondary hypothesis is that the incidence ofchronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 6th month. An other secondary hypothesis is that the total BPI-SF scores will be lower in the RIB group than control group at the postoperative 3rd and the 6th months.

The study is designed as a prospective, double-blinded, randomize controlled study. The patients who will undergo mastectomy surgery with or without axillary dissection will be included in the study. Anesthesia will be inducted with intravenous (iv) thiopental 5 mg/kg, fentanyl 2 mcg/kg and rocuronium bromide 0.6 mg/kg. Following intubation, patients will be allocated into two groups according to a randomization table created by a professional statistician. In the study group, patients will receive a single shot Rhomboid Intercostal Block (RIB) with 30 milliliters of %0.25 bupivacaine and in the control group no block procedure will be performed. All patients will receive a standard analgesia protocol which will include an intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg 15 minutes prior to the end of the surgery. Postoperative pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). Pain scores of the patients will be recorded at the postoperative 15. and 30. min in the recovery room and if the NRS score is 4 or more, iv fentanyl 1 mcg/kg will be applied. At the surgical ward, pain scores will be evaluated at the postoperative 1st, 2nd, 6th, 12th and 24th hours and if the NRS score is 4 or more, iv tramadol 50 mg will be applied as rescue analgesia. Opioid consumptions of the patients will be recorded at the postoperative 24th hour. At the postoperative 3. and 6. months, a pain doctor will evaluate all patients by using Brief Pain Inventory Short Form (BPI-SF) and Douleur Neuropathique 4 (DN4) questionnaire.

The patients will be under general anesthesia and will not be aware if they receive a block procedure or not.

The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups, but she will not involve in data collection.

Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy

The Effect of Single Shot Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy Surgery

The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 3rd month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Primary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 3rd month.

The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 6th month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Secondary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 6th month.

Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 3rd month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 3rd month.

Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 6th month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 6th month.

The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 5th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups.

The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 6th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups at the postoperative 6th month.

Postoperative acute pain of the patients will be evaluated by using Numerical Rating Scale which ranges between 0 point (no pain) and 10 points (worst pain). The 7th outcome of the study is the difference in numerical rating scale scores between study and control groups.

Total opioid consumption of the patients will be recorded at the postoperative 24. hour.

Associated Professor

Breast Diseases

Fibroadenoma

Skin Diseases

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Adjuvants, Anesthesia

Anti-Inflammatory Agents

Antirheumatic Agents

Fentanyl

Ibuprofen

In group P, PECS will be performed with patients in the supine position at the end of the surgery before extubation by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions the high frequency linear probe (11-12 MHz) will be covered with a sterile sheath and a 22G, 50 mm block needle will be used. US probe will be placed on the 4th rib. The muscles PMm, Pmm and Sam will be visualized. At the anterior axillary level or mid-axillary level, via the in-plane technique, Pecs II will be applied by injecting 20 mL of 0.25% bupivacaine in a cephalad to caudad direction to the fascia on Sam.

In group R, RIB block will be performed with patients in the lateral decubitus position at the end of the surgery before extubation. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injectted into the fascial plane.

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

PECS block

Rhomboid intercostal block

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The primary aim of the study is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. It is easy to perform; under ultrasound (US) guidance, the interfascial region between the pectoral muscles (pectoralis major (PMm) and minor (Pmm), serratus anterior Sam) is injected with local anaesthetics. It has been reported that PECS type-2 block provides effective analgesia management for mastectomy and axillary dissection surgeries.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The aim of this study is to evaluate the efficacy of the US-guided PECS-II and RIB for postoperative analgesia management compare to no intervention control group after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

There are three models for this study. Patients will be randomly divided into three groups (Group P = PECS group, Group R = RIB group, Group C = Control group), before entering the operating room.

The anesthesiologist who performs postoperative pain evaluation will not know the group.

Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Comparison of Ultrasound-Guided Type-II Pectoral Nerve Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

The primary aim is to compare postoperative opioid consumption

Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions	NCT05547932	Breast Cancer Postoperative P... Respiratory Fun...	RIB+SAP blocks	18 Years - 65 Years	Muğla Sıtkı Koçman University
Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery	NCT05518292	Breast Cancer	rhomboid interc... serratus anteri...	20 Years - 60 Years	Mansoura University
Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery	NCT05518292	Breast Cancer	rhomboid interc... serratus anteri...	20 Years - 60 Years	Mansoura University
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	NCT06019325	Breast Cancer Postoperative P... Postoperative P... Neuropathic Pai...	RIB	18 Years - 70 Years	Muğla Sıtkı Koçman University
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	NCT06019325	Breast Cancer Postoperative P... Postoperative P... Neuropathic Pai...	RIB	18 Years - 70 Years	Muğla Sıtkı Koçman University
Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery	NCT04297007	Breast Cancer Breast Neoplasm... Breast Diseases Breast Fibroade...	PECS block Rhomboid interc...	18 Years - 65 Years	Medipol University

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