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

NCT03579524 | Completed

• 1 other identifier: M336
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Breast Cancer

Keywords

Erector Spinae Plane Block; Serratus Anterior Plane Block

Outcome Measures

Primary Outcomes (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.

  At 48 hours postoperative

Secondary Outcomes (60)

• The cumulative opioids (morphine) consumption

  At 24 hours postoperative

• The cumulative opioids (morphine) consumption

  At 48 hours postoperative

• The intervals between opioid (morphine) doses

  At 24 hours postoperative

• The intervals between opioid (morphine) doses

  At 48 hours postoperative

• The quality of analgesia based on visual analogue scale (VAS) pain score at rest

  At one hour postoperative

Study Arms (2)

ESPB group

ACTIVE COMPARATOR

Erector Spinae Plane Block administered group

Procedure: Erector Spinae Plane Block

SAPB group

ACTIVE COMPARATOR

Serratus Anterior Plane Block administered group

Procedure: Serratus Anterior Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

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.

Also known as: ESPB

ESPB group

Serratus Anterior Plane Block PROCEDURE

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.

Also known as: SAPB

SAPB group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female Patient with Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (8)

• 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.

  PMID: 28492298 BACKGROUND

• 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.

  PMID: 29065335 BACKGROUND

• 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.

  PMID: 29102405 BACKGROUND

• 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.

  PMID: 29688930 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 23923989 BACKGROUND

• 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.

  PMID: 29777144 BACKGROUND

• 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.

  PMID: 28584346 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hany M. Yassin, MD

  Fayoum University Hospitals

  PRINCIPAL INVESTIGATOR

• Mohamed A. Shawky, MD

  Fayoum University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: August 1, 2018
• Primary Completion: August 15, 2019
• Study Completion: September 15, 2019
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)