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Comparison of Erector Spinae Plane Block With Serratus Anterior Plane Block for Breast Surgery

Primary Purpose

Postoperative Pain, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Serratus Anterior Plane Block
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Erector Spinae Plane Block, Serratus Anterior Plane Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female aged >18 years with breast cancer eligible for modified radical mastectomy.
  • American Society of Anesthesiologists Physical Status I to IV.

Exclusion Criteria:

  • Patient refusal.
  • body mass index (BMI) > 40.
  • local infection at the site of the block.
  • local anesthetic allergy.
  • significant neurological or respiratory disease.

Sites / Locations

  • Fayoum University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESPB group

SAPB group

Arm Description

Erector Spinae Plane Block administered group

Serratus Anterior Plane Block administered group

Outcomes

Primary Outcome Measures

The duration of analgesia of the two blocks
the pain will be assisted based on the time needed for the first dose rescue analgesia.

Secondary Outcome Measures

The cumulative opioids (morphine) consumption
The total amount of opioids received post operative
The cumulative opioids (morphine) consumption
The total amount of opioids received post operative
The intervals between opioid (morphine) doses
the time needed between two successive opioid doses
The intervals between opioid (morphine) doses
the time needed between two successive opioid doses
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Incidences of complications related to both techniques
complications related to the Block or drug administered
Nausea
Morphine related side effect
Nausea
Morphine related side effect
Nausea
Morphine related side effect
Nausea
Morphine related side effect
Nausea
Morphine related side effect
Nausea
Morphine related side effect
Vomiting
Morphine related side effect
Vomiting
Morphine related side effect
Vomiting
Morphine related side effect
Vomiting
Morphine related side effect
Vomiting
Morphine related side effect
Vomiting
Morphine related side effect
Pruritus
Morphine related side effect
Pruritus
Morphine related side effect
Pruritus
Morphine related side effect
Pruritus
Morphine related side effect
Pruritus
Morphine related side effect
Pruritus
Morphine related side effect
Over-sedation
Morphine related side effect
Over-sedation
Morphine related side effect
Over-sedation
Morphine related side effect
Over-sedation
Morphine related side effect
Over-sedation
Morphine related side effect
Over-sedation
Morphine related side effect
Urine retension
Morphine related side effect
Urine retension
Morphine related side effect
Urine retension
Morphine related side effect
Urine retension
Morphine related side effect
Urine retension
Morphine related side effect
Urine retension
Morphine related side effect
The duration of surgery
time needed to perform surgery
Intraoperative fentanyl needed
The amount of Fentanyl given intraoperative as fentanyl will be given when either heart rate or NIBP(Non-Invasive Blood Pressure) report an increase by more than 20% of the basal records
Patients' satisfaction with postoperative analgesia
Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)
Age
In years
weight
In kilograms
Height
In meters
BMI
In kilogram per square meter

Full Information

First Posted
June 25, 2018
Last Updated
November 5, 2020
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03579524
Brief Title
Comparison of Erector Spinae Plane Block With Serratus Anterior Plane Block for Breast Surgery
Official Title
The Effectiveness of Pain Relieve of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block With General Anesthesia in Modified Radical Mastectomy Patient (Randomized Double-Blinded Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Breast cancer is by far the world's most common cancer among women and the most common cause of female death from cancer worldwide. It's worldwide incidence is 43.4 in 100.000 while in Egypt is 48.8 in 100.000. One of the most common surgical procedures for it is modified radical mastectomy (MRM), It is account for 31% of all breast surgery cases. Post-mastectomy pain is a big problem affecting the outcome of surgery. It was used to be managed by opioids which may lead to many side effects such as nausea, vomiting, ileus, over sedation and respiratory depression. Chronic pain syndrome (phantom breast pain, paraesthesias, and intercostobrachial neuralgia) may be developed due to inadequate pain control. So many regional analgesic techniques have been developed for effective pain control. The safest and easiest is local wound infiltration with local anesthesia but the duration of action is limited. Intercostal nerve block and interpleural block are effective, but there is a fear of pneumothorax and transient Horner's syndrome. Thoracic epidural analgesia is not preferred however it's efficacy because of possible neurological and hemodynamic side effects. The gold standard now is thoracic paravertebral block (PVB) which provide effective analgesia with minimal hemodynamic derangement but it carries a risk of pneumothorax in addition to slightly complex technique. Ultrasound-guided interfascial plane blocks such as pectoral nerve (PECS) block type 1 and 2 , serratus anterior plane block (SAPB) and erector spinae plane block (ESP) which is a recent block newly described for various surgeries for postoperative analgesia have also been reported as alternatives, with the advantages of simplicity, ease of performance and fewer complications. there is no sufficient Randomized controlled trails that assess the effectiveness and safety of erector spinae plane block ESPB in controlling post mastectomy pain This study compares the analgesic efficacy of ultrasound-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) in patients undergoing MRM with axillary dissection.
Detailed Description
Preoperative preparation: History taking, physical examination, and investigations will be done according to the local protocol designed to evaluate the patients. This includes complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile and electrocardiogram (ECG). Before surgery, the participants will receive education about the VAS pain score (0-100 mm) (where0=no pain and 100 = worst comprehensible pain) and the details of the nerve block procedures. After 6 hours of fasting, the patients will be taken to the operation theatre. Anesthetic management: The patient will receive Midazolam 0.03 mg/kg intravenous (IV), Metoclopramide 10 mg IV, Ranitidine 50 mg IV and Cefotaxime 1 gm as a premedication. Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure (NIBP) and capnography) will be applied. All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of End Tidal Carbon Dioxide Tension (EtCO2) ≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperatively when either heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria. A high-frequency ultrasound probe Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips Healthcare, Andover MA01810™, USA).and a 22-gauge, 50 mm echogenic needle (Stimuplex D®; B Braun, Germany) will be used for performing the blocks. Patients in group (S) will receive serratus anterior plane block and those in group (E) will receive Erector spinae plane block. Both of these blocks will be performed after induction of general anesthesia by an experienced anesthesiologist (who is well trained in ultrasound-guided regional anesthesia). After proper skin sterilization with povidone-iodine solution. For the ultrasound-guided serratus anterior plane block, the patient will be placed in supine position with the arm abducted. Ribs will be counted in the mid-axillary line from downward upwards until the 5th ribs the linear probe will be placed horizontally then three muscles will be identified: latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior) .the thoracodorsal artery (slightly posterior) will be used as extra guide in the identification of the plane superficial to the serratus muscle. The needle will be inserted in-plane with respect to the ultrasound probe from supero-anterior to postero-inferior. 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread over serratus anterior muscles, then a total 20 ml of bupivacaine 0.25% will be injected. For the ultrasound-guided erector spinae plane block At first the patient will be placed in a lateral decubitus with the operation site up. The vertebrae will be counted from cephalad to caudal direction until we reach T5 spinous process as the first palpable spinous process is C7. Ultrasound probe will be placed vertically 3 cm lateral to the T5 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle will be introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle (the needle tip contacts the tip of the transverse process), 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread under erector spinae muscle a total of 20 mL of 0.25% bupivacaine will be injected next. Post-operative care Patients will be transferred to post-anesthetic care unit (PACU) for 2 hrs after anesthesia emergence. The patients will be discharged from the PACU after fulfilling the discharge criteria based on the modified Aldrete score> 9 The patient will receive analgesic according to the local institutional protocol as the following (paracetamol 1gm IV infusion/8 hours, ketorolac 30 mg Intramuscular/12 hours) as 2 components of multimodal anesthesia regimen for postoperative pain control. A postoperative rescue analgesia with morphine sulfate IV per a titration protocol (3 mg IV as a bolus dose which can be repeated every 5 minutes with a maximum dose of 15mg per 4 hours or 45mg per 24 hours) will be employed if visual analog pain scale (VAS) > 4. The morphine titration protocol will be suspended with Oxygen saturation < 95%; Respiratory rate < 10 / min; the development of sedation (Ramsay sedation scale >2); development of acute adverse effects (allergy, marked itching, excessive vomiting, and hypotension with systolic blood pressure less than 20% of baseline values); or attaining adequate level of analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Cancer
Keywords
Erector Spinae Plane Block, Serratus Anterior Plane Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block administered group
Arm Title
SAPB group
Arm Type
Active Comparator
Arm Description
Serratus Anterior Plane Block administered group
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Other Intervention Name(s)
ESPB
Intervention Description
At lateral decubitus with the operation site up, the vertebrae will be counted from cephalad to caudal direction until reaching T5 spinous process as the first palpable spinous process is C7. The ultrasound probe will be placed vertically 3 cm lateral to the T5 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle will be introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle. 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread under erector spinae muscle. A total of 20 mL of 0.25% bupivacaine will be injected next.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane Block
Other Intervention Name(s)
SAPB
Intervention Description
At supine position with the arm abducted, the ribs will be counted in the mid-axillary line from downward upwards until the 5th ribs. The linear probe will be placed horizontally then three muscles will be identified: latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior). The needle will be inserted in-plane with respect to the ultrasound probe from supero-anterior to posteroinferior. 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread over serratus anterior muscles, then a total 20 ml of bupivacaine 0.25% will be injected.
Primary Outcome Measure Information:
Title
The duration of analgesia of the two blocks
Description
the pain will be assisted based on the time needed for the first dose rescue analgesia.
Time Frame
At 48 hours postoperative
Secondary Outcome Measure Information:
Title
The cumulative opioids (morphine) consumption
Description
The total amount of opioids received post operative
Time Frame
At 24 hours postoperative
Title
The cumulative opioids (morphine) consumption
Description
The total amount of opioids received post operative
Time Frame
At 48 hours postoperative
Title
The intervals between opioid (morphine) doses
Description
the time needed between two successive opioid doses
Time Frame
At 24 hours postoperative
Title
The intervals between opioid (morphine) doses
Description
the time needed between two successive opioid doses
Time Frame
At 48 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At one hour postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 6 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 12 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 18 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 24 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 30 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 36 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 42 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at rest
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 48 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At one hour postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 6 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 12 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 18 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 24 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 30 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 36 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 42 hours postoperative
Title
The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 48 hours postoperative
Title
Incidences of complications related to both techniques
Description
complications related to the Block or drug administered
Time Frame
up to 72 hours postoperative
Title
Nausea
Description
Morphine related side effect
Time Frame
At 2 hours postoperative
Title
Nausea
Description
Morphine related side effect
Time Frame
At 6 hours postoperative
Title
Nausea
Description
Morphine related side effect
Time Frame
At 12 hours postoperative
Title
Nausea
Description
Morphine related side effect
Time Frame
At 24 hours postoperative
Title
Nausea
Description
Morphine related side effect
Time Frame
At 48 hours postoperative
Title
Nausea
Description
Morphine related side effect
Time Frame
At 72 hours postoperative
Title
Vomiting
Description
Morphine related side effect
Time Frame
At 2 hours postoperative
Title
Vomiting
Description
Morphine related side effect
Time Frame
At 6 hours postoperative
Title
Vomiting
Description
Morphine related side effect
Time Frame
At 12 hours postoperative
Title
Vomiting
Description
Morphine related side effect
Time Frame
At 24 hours postoperative
Title
Vomiting
Description
Morphine related side effect
Time Frame
At 48 hours postoperative
Title
Vomiting
Description
Morphine related side effect
Time Frame
At 72 hours postoperative
Title
Pruritus
Description
Morphine related side effect
Time Frame
At 2 hours postoperative
Title
Pruritus
Description
Morphine related side effect
Time Frame
At 6 hours postoperative
Title
Pruritus
Description
Morphine related side effect
Time Frame
At 12 hours postoperative
Title
Pruritus
Description
Morphine related side effect
Time Frame
At 24 hours postoperative
Title
Pruritus
Description
Morphine related side effect
Time Frame
At 48 hours postoperative
Title
Pruritus
Description
Morphine related side effect
Time Frame
At 72 hours postoperative
Title
Over-sedation
Description
Morphine related side effect
Time Frame
At 2 hours postoperative
Title
Over-sedation
Description
Morphine related side effect
Time Frame
At 6 hours postoperative
Title
Over-sedation
Description
Morphine related side effect
Time Frame
At 12 hours postoperative
Title
Over-sedation
Description
Morphine related side effect
Time Frame
At 24 hours postoperative
Title
Over-sedation
Description
Morphine related side effect
Time Frame
At 48 hours postoperative
Title
Over-sedation
Description
Morphine related side effect
Time Frame
At 72 hours postoperative
Title
Urine retension
Description
Morphine related side effect
Time Frame
At 2 hours postoperative
Title
Urine retension
Description
Morphine related side effect
Time Frame
At 6 hours postoperative
Title
Urine retension
Description
Morphine related side effect
Time Frame
At 12 hours postoperative
Title
Urine retension
Description
Morphine related side effect
Time Frame
At 24 hours postoperative
Title
Urine retension
Description
Morphine related side effect
Time Frame
At 48 hours postoperative
Title
Urine retension
Description
Morphine related side effect
Time Frame
At 72 hours postoperative
Title
The duration of surgery
Description
time needed to perform surgery
Time Frame
Once at completion of surgery
Title
Intraoperative fentanyl needed
Description
The amount of Fentanyl given intraoperative as fentanyl will be given when either heart rate or NIBP(Non-Invasive Blood Pressure) report an increase by more than 20% of the basal records
Time Frame
Once at completion of surgery
Title
Patients' satisfaction with postoperative analgesia
Description
Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)
Time Frame
after 72 hours postoperative
Title
Age
Description
In years
Time Frame
Once the patient is recruited
Title
weight
Description
In kilograms
Time Frame
Once the patient is recruited
Title
Height
Description
In meters
Time Frame
Once the patient is recruited
Title
BMI
Description
In kilogram per square meter
Time Frame
Once the patient is recruited

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female Patient with Breast Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female aged >18 years with breast cancer eligible for modified radical mastectomy. American Society of Anesthesiologists Physical Status I to IV. Exclusion Criteria: Patient refusal. body mass index (BMI) > 40. local infection at the site of the block. local anesthetic allergy. significant neurological or respiratory disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany M. Yassin, MD
Organizational Affiliation
Fayoum University Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed A. Shawky, MD
Organizational Affiliation
Fayoum University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fayoum University hospital
City
Madīnat al Fayyūm
State/Province
Faiyum Governorate
ZIP/Postal Code
63514
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28492298
Citation
Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.
Results Reference
background
PubMed Identifier
29065335
Citation
Bonvicini D, Tagliapietra L, Giacomazzi A, Pizzirani E. Bilateral ultrasound-guided erector spinae plane blocks in breast cancer and reconstruction surgery. J Clin Anesth. 2018 Feb;44:3-4. doi: 10.1016/j.jclinane.2017.10.006. Epub 2017 Oct 21. No abstract available.
Results Reference
background
PubMed Identifier
29102405
Citation
Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.
Results Reference
background
PubMed Identifier
29688930
Citation
Kimachi PP, Martins EG, Peng P, Forero M. The Erector Spinae Plane Block Provides Complete Surgical Anesthesia in Breast Surgery: A Case Report. A A Pract. 2018 Oct 1;11(7):186-188. doi: 10.1213/XAA.0000000000000777.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
23923989
Citation
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
Results Reference
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PubMed Identifier
29777144
Citation
Matsumoto M, Flores EM, Kimachi PP, Gouveia FV, Kuroki MA, Barros ACSD, Sampaio MMC, Andrade FEM, Valverde J, Abrantes EF, Simoes CM, Pagano RL, Martinez RCR. Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia. Sci Rep. 2018 May 18;8(1):7815. doi: 10.1038/s41598-018-26273-z.
Results Reference
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PubMed Identifier
28584346
Citation
Gupta K, Srikanth K, Girdhar KK, Chan V. Analgesic efficacy of ultrasound-guided paravertebral block versus serratus plane block for modified radical mastectomy: A randomised, controlled trial. Indian J Anaesth. 2017 May;61(5):381-386. doi: 10.4103/ija.IJA_62_17.
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Comparison of Erector Spinae Plane Block With Serratus Anterior Plane Block for Breast Surgery

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