Modified Pectoral Nerve Block Versus Serratus Plane Block
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound guided Nerve Block procedure
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Breast cancer surgery.
- Age 20 to 60 years.
- Female patients.
- At least 24 hours post-operative hospital admission.
- ASA (American society of anesthesiologist) physical status classification system І to Ш.
Exclusion Criteria:
• Morbid obesity (body mass index > 40).
- Impossibility of anatomical structures identification by ultrasound in a satisfactory way (there can be no distinction in the interfacial plan between serratus and pectoral muscle).
- Opioids treatment before surgery or substance abuse.
- Sepsis and/or infection at the puncture site.
- Hemostasis disorders.
- Allergy to any of the drugs used in the study.
- Less than 24 hours postoperative hospital admission.
- Inability to communicate with the patient.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: (30 patients)
Group B: (30 patients)
Arm Description
modified pectoral nerve block will be done.
serratus plane block will be done.
Outcomes
Primary Outcome Measures
assess analgesic effect of nerve block
We assess the analgesic effect by VAS ( visual analogue scale )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04895397
Brief Title
Modified Pectoral Nerve Block Versus Serratus Plane Block
Official Title
Modified Pectoral Nerve Block Versus Serratus Plane Block for Analgesia After Breast Cancer Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2021 (Anticipated)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012).
In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).
Detailed Description
One hour before induction of anesthesia 4ml blood sample will be taken from all patient to measure serum cortisol and serum endorphin level 2ml for each.
General anesthesia will be induced for all patients in both groups using the same protocol.
Anesthesia will be induced with propfol (2-3 mg/kg), IV rocuroniom (.5 - .8 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained with isoflurane (1-2 mac) in 100% oxygen.
All patients will be intubated and mechanically ventilated using volume controlled positive pressure ventilation with a tidal volume of 6-8 ml/kg and an inspiratory to expiratory ratio of 1:2 targeting end tidal carbon dioxide tension around 35mmhg.
Basic monitoring for all patients include under pulse oximetry, non-invasive blood pressure, 5 lead electrocardiogram and end tidal carbon dioxide monitoring.
In group A patients, an ultrasound guided modified pectoral nerve block will be performed after induction of general anesthesia. Under sterile conditions, US-guided PECSII block will be on the same side of surgery with the patient lying in the supine position with the ipsilateral arm abducted and externally rotated, and the elbow flexed 90°. The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.
After identification of the Pectoralis major muscle, Pectoralis minor muscle and the plane in between, the probe will be tilted caudally to identify the pulsating pectoral branch of the thoracoacromial artery, if not identified, the probe will be moved 1-2 cm caudally and medially. In a caudal tilt, the artery will be easily identified in a biconvex space.
The skin at the point of entry was infiltrated using lidocaine 1%; then, the needle (disposable spinal needle, K-3 point type LUER-Lock HUB 22G) will be advanced in an in-plane technique targeting the space in which the artery is located. Two mL of saline 0.9% will be injected to confirm the location, produce hydro-dissection, and improve needle visualization. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.
Then, the probe will be moved laterally and caudally towards the anterior axillary fold, parallel to the deltopectoral groove, until the serratus muscle appears underneath the Pectoralis minor muscle attached to the underlying ribs.
The 3rd, fourth ribs and the pleura will be then identified. After infiltration of the skin with lidocaine 1%, the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.
Group B: In SAPB Group, a US-guided serratus block will be done with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.
The ribs, pleura, and overlying serratus muscle will be identified, and the needle will be advanced cephalad in-plane until the tip touched the 4th rib. Afterward, 2 mL saline 0.9% will be injected; then, 20 mL of bupivacaine 0.25% will be injected in the plane between the serratus and the 4th rib.
At the end of the surgery, the muscle relaxant will be reversed using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After fully awake extubation, all patients will be transferred to the post-anesthesia care unit (PACU).
Two hour post-operative 4ml blood sample will be taken from all patients to measure serum cortisol and serum endorphin level 2ml for each.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: (30 patients) modified pectoral nerve block will be done.
Group B: (30 patients) serratus plane block will be done.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: (30 patients)
Arm Type
Active Comparator
Arm Description
modified pectoral nerve block will be done.
Arm Title
Group B: (30 patients)
Arm Type
Active Comparator
Arm Description
serratus plane block will be done.
Intervention Type
Device
Intervention Name(s)
ultrasound guided Nerve Block procedure
Intervention Description
In group A patients, an ultrasound guided modified pectoral nerve block will be performed Under sterile conditions, US-guided PECSII block will be on the same side of surgery . The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.
the needle will be advanced in an in-plane technique targeting the space in which the artery is located. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.
the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.
Group B: In SAPB Group, a US-guided serratus block will be done The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.
Primary Outcome Measure Information:
Title
assess analgesic effect of nerve block
Description
We assess the analgesic effect by VAS ( visual analogue scale )
Time Frame
24hour post-operative
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Breast cancer surgery.
Age 20 to 60 years.
Female patients.
At least 24 hours post-operative hospital admission.
ASA (American society of anesthesiologist) physical status classification system І to Ш.
Exclusion Criteria:
• Morbid obesity (body mass index > 40).
Impossibility of anatomical structures identification by ultrasound in a satisfactory way (there can be no distinction in the interfacial plan between serratus and pectoral muscle).
Opioids treatment before surgery or substance abuse.
Sepsis and/or infection at the puncture site.
Hemostasis disorders.
Allergy to any of the drugs used in the study.
Less than 24 hours postoperative hospital admission.
Inability to communicate with the patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed hussein, lecturer
Phone
01005872429
Email
mohamedhussin@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed hussein, lecturer
Phone
01005872429
Email
mohamedhussin@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed hussein, lecturer
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Modified Pectoral Nerve Block Versus Serratus Plane Block
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