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The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.
During MRM , some of the nerves in the chest are affected so most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery is an independent risk factor in the development of chronic post-mastectomy pain , not only increasing the risk of persistent agony and prolongs hospitalization, it also affects recovery and increases healthcare costs .
Multimodal techniques for pain management have been recommended by the American Society of Anesthesiologists (ASA) for the management of acute postoperative pain . These techniques include oral analgesics as opioids, paracetamol and nonsteroidal anti inflammatory drugs (NSAIDs) , intravenous (IV) and regional analgesia. Inappropriate postoperative analgesia may increase morbidity and mortality .
PECS-II block is an interfascial plane block in which local anesthetic is injected between serratus anterior and pectoralis muscles that blocks the pectoral nerve as well as the long thoracic, intercostobrachial and lateral cutaneous branches of the inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to be performed alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides safe and adequate post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, vascular puncture, infection, local anesthetic systemic toxicity (LAST), allergy and failed block .
ESPB is a paraspinal fascial plane block in which local anesthetic is injected between the tip of the transverse process of the spine and the anterior fascia of the erector spinae muscles blocking the dorsal and ventral rami of the spinal nerves, as well as the sympathetic chain, resulting in analgesia of chronic thoracic neuropathic pain, breast and upper abdominal surgeries. The block, defined by Forero et al., can cover several spinal nerve levels above and below the injection site as the local anesthetic spreads along the fascial plane, depending on the volume and concentration of the local anesthetic . The main advantages of this technique include the ease of performing it, the analgesic efficacy and the low risk of complications as Pneumothorax, hemi-diaphragmatic paralysis, motor weakness, and neurological findings related to local anesthesia toxicity .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-Guided Modified Pectoral Plane Block group | Active Comparator | first group 10 patients |
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| Erector Spinae Plane Block group | Active Comparator | second group 10 patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Pectoral Plane block group | Procedure | The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. | Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome | will be evaluated postoperatively on arrival to PACU (zero time) |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable). | 24 hours post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ibrahim, MD | Faculty Of Medicine , Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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Twenty patients were enrolled and randomly divided into the two groups , 10 patients each .
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Pectoral Plane Block Group | first group 10 patients Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine. |
| FG001 | Erector Spinae Plane Block Group | second group 10 patients Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pectoral Plane Block Group | first group 10 patients Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. | Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome | Posted | Mean | Standard Deviation | score on a scale | will be evaluated postoperatively on arrival to PACU (zero time) |
|
24 hours postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Pectoral Plane Block Group | first group 10 patients Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed Ibrahim , Lecturer of anesthesia | Ain Shams university | 01115560811 | 002 | T.majestic@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2024 | Dec 20, 2024 | Prot_SAP_000.pdf |
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| Erector spinae plane block group. | Procedure | The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. |
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| BG001 | Erector Spinae Plane Block Group | second group 10 patients Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kilograms |
|
| height | Mean | Standard Deviation | centimeters |
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| breast-side | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kilogram per meter squared |
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| ASA Classification | The American Society of Anesthesiologists (ASA) physical status classification system is a grading system to determine the health of a person before a surgical procedure that requires anesthesia where ASA I is a normal healthy patient ASA II a patient with mild systemic disease ASA III a patient with severe systemic disease ASA IV a patient with severe systemic disease that is a constant threat to life ASA V a moribund patient who is not expected to survive without the operation ASA VI a declared brain-dead patient whose organs are being removed for donor purposes | Number | participants |
|
| operation duration | Mean | Standard Deviation | minutes |
|
| OG001 | Erector Spinae Plane Block Group | second group 10 patients Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. |
|
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| Secondary | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-operative |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Erector Spinae Plane Block Group | second group 10 patients Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Post-operative pain severity assessed by Visual analogue scale at 8 hours postoperatively. |
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| Post-operative pain severity assessed by Visual analogue scale at 12 hours postoperatively. |
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| Post-operative pain severity assessed by Visual analogue scale at 18 hours postoperatively. |
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| Post-operative pain severity assessed by Visual analogue scale at 24 hours postoperatively. |
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