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Postoperative PainNCT03579524

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

A study testing Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Postoperative Pain and Breast Cancer, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postoperative Pain, Breast Cancer
What is being tested?
Erector Spinae Plane Block and Serratus Anterior Plane Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteEgypt
Study dates
1 Aug 2018to 15 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

    El Fayoum Qesm, Faiyum Governorate, 63514

Other trials in Egypt

About this study

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)

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.

Read more

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.

Read the 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.

Being tested
Erector Spinae Plane Block, Serratus Anterior Plane Block
Keywords
Erector Spinae Plane Block, Serratus Anterior Plane Block
Medical subject headings
Pain, Postoperative, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane BlockProcedure or surgery

    Also called ESPB

    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.

  • Serratus Anterior Plane BlockProcedure or surgery

    Also called SAPB

    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.

Study groups in NCT03579524
Study groupRoleWhat they receive
ESPB groupActive comparatorErector Spinae Plane Block administered group
Receives: Procedure: Erector Spinae Plane Block
SAPB groupActive comparatorSerratus Anterior Plane Block administered group
Receives: Procedure: Serratus Anterior Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The duration of analgesia of the two blocks

    the pain will be assisted based on the time needed for the first dose rescue analgesia.

    Measured: At 48 hours postoperative

Secondary outcomes (60)
  1. The cumulative opioids (morphine) consumption

    The total amount of opioids received post operative

    Measured: At 24 hours postoperative

  2. The cumulative opioids (morphine) consumption

    The total amount of opioids received post operative

    Measured: At 48 hours postoperative

  3. The intervals between opioid (morphine) doses

    the time needed between two successive opioid doses

    Measured: At 24 hours postoperative

  4. The intervals between opioid (morphine) doses

    the time needed between two successive opioid doses

    Measured: At 48 hours postoperative

  5. 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

    Measured: At one hour postoperative

  6. 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

    Measured: At 6 hours postoperative

  7. 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

    Measured: At 12 hours postoperative

  8. 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

    Measured: At 18 hours postoperative

  9. 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

    Measured: At 24 hours postoperative

  10. 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

    Measured: At 30 hours postoperative

  11. 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

    Measured: At 36 hours postoperative

  12. 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

    Measured: At 42 hours postoperative

  13. 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

    Measured: At 48 hours postoperative

  14. 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

    Measured: At one hour postoperative

  15. 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

    Measured: At 6 hours postoperative

  16. 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

    Measured: At 12 hours postoperative

  17. 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

    Measured: At 18 hours postoperative

  18. 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

    Measured: At 24 hours postoperative

  19. 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

    Measured: At 30 hours postoperative

  20. 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

    Measured: At 36 hours postoperative

  21. 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

    Measured: At 42 hours postoperative

  22. 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

    Measured: At 48 hours postoperative

  23. Incidences of complications related to both techniques

    complications related to the Block or drug administered

    Measured: up to 72 hours postoperative

  24. Nausea

    Morphine related side effect

    Measured: At 2 hours postoperative

  25. Nausea

    Morphine related side effect

    Measured: At 6 hours postoperative

  26. Nausea

    Morphine related side effect

    Measured: At 12 hours postoperative

  27. Nausea

    Morphine related side effect

    Measured: At 24 hours postoperative

  28. Nausea

    Morphine related side effect

    Measured: At 48 hours postoperative

  29. Nausea

    Morphine related side effect

    Measured: At 72 hours postoperative

  30. Vomiting

    Morphine related side effect

    Measured: At 2 hours postoperative

  31. Vomiting

    Morphine related side effect

    Measured: At 6 hours postoperative

  32. Vomiting

    Morphine related side effect

    Measured: At 12 hours postoperative

  33. Vomiting

    Morphine related side effect

    Measured: At 24 hours postoperative

  34. Vomiting

    Morphine related side effect

    Measured: At 48 hours postoperative

  35. Vomiting

    Morphine related side effect

    Measured: At 72 hours postoperative

  36. Pruritus

    Morphine related side effect

    Measured: At 2 hours postoperative

  37. Pruritus

    Morphine related side effect

    Measured: At 6 hours postoperative

  38. Pruritus

    Morphine related side effect

    Measured: At 12 hours postoperative

  39. Pruritus

    Morphine related side effect

    Measured: At 24 hours postoperative

  40. Pruritus

    Morphine related side effect

    Measured: At 48 hours postoperative

  41. Pruritus

    Morphine related side effect

    Measured: At 72 hours postoperative

  42. Over-sedation

    Morphine related side effect

    Measured: At 2 hours postoperative

  43. Over-sedation

    Morphine related side effect

    Measured: At 6 hours postoperative

  44. Over-sedation

    Morphine related side effect

    Measured: At 12 hours postoperative

  45. Over-sedation

    Morphine related side effect

    Measured: At 24 hours postoperative

  46. Over-sedation

    Morphine related side effect

    Measured: At 48 hours postoperative

  47. Over-sedation

    Morphine related side effect

    Measured: At 72 hours postoperative

  48. Urine retension

    Morphine related side effect

    Measured: At 2 hours postoperative

  49. Urine retension

    Morphine related side effect

    Measured: At 6 hours postoperative

  50. Urine retension

    Morphine related side effect

    Measured: At 12 hours postoperative

  51. Urine retension

    Morphine related side effect

    Measured: At 24 hours postoperative

  52. Urine retension

    Morphine related side effect

    Measured: At 48 hours postoperative

  53. Urine retension

    Morphine related side effect

    Measured: At 72 hours postoperative

  54. The duration of surgery

    time needed to perform surgery

    Measured: Once at completion of surgery

  55. 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

    Measured: Once at completion of surgery

  56. Patients' satisfaction with postoperative analgesia

    Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)

    Measured: after 72 hours postoperative

  57. Age

    In years

    Measured: Once the patient is recruited

  58. weight

    In kilograms

    Measured: Once the patient is recruited

  59. Height

    In meters

    Measured: Once the patient is recruited

  60. BMI

    In kilogram per square meter

    Measured: Once the patient is recruited

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start1 Aug 2018
  3. Primary completion15 Aug 2019
  4. Study completion15 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579524
Sponsor's protocol ID
M336
Status last verified
Nov 2020
First submitted
25 Jun 2018
Last updated
9 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28492298
  • 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.

    PubMed 29065335
  • 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.

    PubMed 29102405
  • 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.

    PubMed 29688930
  • 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.

    PubMed 27501016
  • 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.

    PubMed 23923989
  • 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.

    PubMed 29777144
  • 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.

    PubMed 28584346

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Postoperative Pain and Breast Cancer, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The duration of analgesia of the two blocks (time frame: At 48 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579524, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.

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