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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579524
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hany M Yassin, MD, Fayoum University Hospital

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Breast Cancer Procedure: Erector Spinae Plane Block Procedure: Serratus Anterior Plane Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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)
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : August 15, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ESPB group
Erector Spinae Plane Block administered group
Procedure: Erector Spinae Plane Block
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.
Other Name: ESPB

Active Comparator: SAPB group
Serratus Anterior Plane Block administered group
Procedure: Serratus Anterior Plane Block
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.
Other Name: SAPB




Primary Outcome Measures :
  1. The duration of analgesia of the two blocks [ Time Frame: At 48 hours postoperative ]
    the pain will be assisted based on the time needed for the first dose rescue analgesia.


Secondary Outcome Measures :
  1. The cumulative opioids (morphine) consumption [ Time Frame: At 24 hours postoperative ]
    The total amount of opioids received post operative

  2. The cumulative opioids (morphine) consumption [ Time Frame: At 48 hours postoperative ]
    The total amount of opioids received post operative

  3. The intervals between opioid (morphine) doses [ Time Frame: At 24 hours postoperative ]
    the time needed between two successive opioid doses

  4. The intervals between opioid (morphine) doses [ Time Frame: At 48 hours postoperative ]
    the time needed between two successive opioid doses

  5. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At one hour postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  6. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 6 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  7. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 12 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  8. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 18 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  9. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 24 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  10. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 30 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  11. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 36 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  12. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 42 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  13. The quality of analgesia based on visual analogue scale (VAS) pain score at rest [ Time Frame: At 48 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  14. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At one hour postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  15. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 6 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  16. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 12 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  17. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 18 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  18. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 24 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  19. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 30 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  20. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 36 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  21. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 42 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  22. The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction [ Time Frame: At 48 hours postoperative ]
    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  23. Incidences of complications related to both techniques [ Time Frame: up to 72 hours postoperative ]
    complications related to the Block or drug administered

  24. Nausea [ Time Frame: At 2 hours postoperative ]
    Morphine related side effect

  25. Nausea [ Time Frame: At 6 hours postoperative ]
    Morphine related side effect

  26. Nausea [ Time Frame: At 12 hours postoperative ]
    Morphine related side effect

  27. Nausea [ Time Frame: At 24 hours postoperative ]
    Morphine related side effect

  28. Nausea [ Time Frame: At 48 hours postoperative ]
    Morphine related side effect

  29. Nausea [ Time Frame: At 72 hours postoperative ]
    Morphine related side effect

  30. Vomiting [ Time Frame: At 2 hours postoperative ]
    Morphine related side effect

  31. Vomiting [ Time Frame: At 6 hours postoperative ]
    Morphine related side effect

  32. Vomiting [ Time Frame: At 12 hours postoperative ]
    Morphine related side effect

  33. Vomiting [ Time Frame: At 24 hours postoperative ]
    Morphine related side effect

  34. Vomiting [ Time Frame: At 48 hours postoperative ]
    Morphine related side effect

  35. Vomiting [ Time Frame: At 72 hours postoperative ]
    Morphine related side effect

  36. Pruritus [ Time Frame: At 2 hours postoperative ]
    Morphine related side effect

  37. Pruritus [ Time Frame: At 6 hours postoperative ]
    Morphine related side effect

  38. Pruritus [ Time Frame: At 12 hours postoperative ]
    Morphine related side effect

  39. Pruritus [ Time Frame: At 24 hours postoperative ]
    Morphine related side effect

  40. Pruritus [ Time Frame: At 48 hours postoperative ]
    Morphine related side effect

  41. Pruritus [ Time Frame: At 72 hours postoperative ]
    Morphine related side effect

  42. Over-sedation [ Time Frame: At 2 hours postoperative ]
    Morphine related side effect

  43. Over-sedation [ Time Frame: At 6 hours postoperative ]
    Morphine related side effect

  44. Over-sedation [ Time Frame: At 12 hours postoperative ]
    Morphine related side effect

  45. Over-sedation [ Time Frame: At 24 hours postoperative ]
    Morphine related side effect

  46. Over-sedation [ Time Frame: At 48 hours postoperative ]
    Morphine related side effect

  47. Over-sedation [ Time Frame: At 72 hours postoperative ]
    Morphine related side effect

  48. Urine retension [ Time Frame: At 2 hours postoperative ]
    Morphine related side effect

  49. Urine retension [ Time Frame: At 6 hours postoperative ]
    Morphine related side effect

  50. Urine retension [ Time Frame: At 12 hours postoperative ]
    Morphine related side effect

  51. Urine retension [ Time Frame: At 24 hours postoperative ]
    Morphine related side effect

  52. Urine retension [ Time Frame: At 48 hours postoperative ]
    Morphine related side effect

  53. Urine retension [ Time Frame: At 72 hours postoperative ]
    Morphine related side effect

  54. The duration of surgery [ Time Frame: Once at completion of surgery ]
    time needed to perform surgery

  55. Intraoperative fentanyl needed [ Time Frame: Once at completion of surgery ]
    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

  56. Patients' satisfaction with postoperative analgesia [ Time Frame: after 72 hours postoperative ]
    Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)

  57. Age [ Time Frame: Once the patient is recruited ]
    In years

  58. weight [ Time Frame: Once the patient is recruited ]
    In kilograms

  59. Height [ Time Frame: Once the patient is recruited ]
    In meters

  60. BMI [ Time Frame: Once the patient is recruited ]
    In kilogram per square meter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female Patient with Breast Cancer
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579524


Locations
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Egypt
Fayoum University hospital
Madīnat al Fayyūm, Faiyum Governorate, Egypt, 63514
Sponsors and Collaborators
Fayoum University Hospital
Investigators
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Principal Investigator: Hany M. Yassin, MD Fayoum University Hospitals
Study Chair: Mohamed A. Shawky, MD Fayoum University Hospital
Publications:

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Responsible Party: Hany M Yassin, MD, Associated professor, Fayoum University Hospital
ClinicalTrials.gov Identifier: NCT03579524    
Other Study ID Numbers: M336
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hany M Yassin, MD, Fayoum University Hospital:
Erector Spinae Plane Block
Serratus Anterior Plane Block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations