Effectiveness of Ultrasound Guided Erector Spinae Plane Block Against Ultrasound Guided Serratus Anterior Block in Modified Radical Mastectomy

NCT04606147 | Completed DMC

• 1 other identifier: MS-268-2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare and evaluate the safety and analgesic efficacy of ultrasound guided ESP block and ultrasound guided serratus anterior plane block in patients undergoing modified radical mastectomy.

Conditions

Breast Cancer; Postoperative Pain

Keywords

Modified Radical Mastectomy MRM, ESPB ,SAPB , Regional anesthesia and postoperative analgesia.

Outcome Measures

Primary Outcomes (1)

• Total amount of postoperative morphine consumption in 24 hours. (mg)

  Total amount of postoperative morphine consumption in 24 hours. (mg)

  24 hours

Secondary Outcomes (8)

• Total amount of intraoperative fentanyl consumption (mcg)

  duration of surgery

• Change in heart rate intraoperatively

  duration of surgery

• The degree of postoperative sedation according to Ramsay scores.

  24 hours

• Time to first rescue analgesia (hours)

  postoperative

• Numeric Pain Rating Scale score, both at rest and during movement

  24 hours

Study Arms (2)

Group 1 ((Serratus Anterior Plane Block SAPB)) N=3o

EXPERIMENTAL

Patients received Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml levobupivacaine 0.25%. Then patients were transferred to the operating room.

Procedure: Serratus Anterior Plane Block

Group 2 ((Erector Spinae Plane Block ESPB)) N=3o

EXPERIMENTAL

Patients received Ultrasound guided erector spinae plane block with injection of 30 ml levobupivacaine 0.25%. Then patients were transferred to the operating room.

Procedure: Erector spinae plane block

Interventions

Serratus Anterior Plane Block PROCEDURE

The block is performed with full aseptic precautions.in lateral position \&arm abduction. US probe placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib.With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, the skin and subcutaneous tissue can be topicalized. Then, using ultrasound guidance, A regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib.Correct location of the needle tip in the fascial plane deep to serratus anterior muscle will be confirmed by injecting 0.5-1 ml normal saline and seeing hydrodissection of fascial plane between SAM and 5th rib. After aspiration to avoid intravascular injection 30 ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle. The entirety of the needle should be visualized at all times throughout the procedure.

Group 1 ((Serratus Anterior Plane Block SAPB)) N=3o

Erector spinae plane block PROCEDURE

The block is performed with full aseptic precautions at T5 level. T5 transverse process is identified by us as flat, squared-off acoustic shadows with only a very faint image of the pleura.In longitudinal us view following layers will be visible superficial to transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle.Skin is topicalised , then echogenic block needle inserted in- plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. After aspiration to avoid intravascular injection 30 ml levobupivacaine 0.25% was injected and separation was seen. 6-13-MHz, linear transducer set for small parts and a depth of 4-6 cm was used

Group 2 ((Erector Spinae Plane Block ESPB)) N=3o

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• Type of surgery; Modified Radical Mastectomy MRM
• Physical status ASA II, III.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.

You may not qualify if:

• Age: ≤18 years or ≥65 years
• BMI: ≤20 kg/m2 or ≥ 35 kg/m2
• Known sensitivity or contraindication to drugs used in the study (local anaesthetics, opioids).
• History of psychological disorders and/or chronic pain syndrome.
• Contraindication to regional anaesthesia e.g. local sepsis, pre-existing peripheral neuropathies and coagulopathy.
• Patient refusal.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease.
• Pregnancy.
• Physical status ASA IV
• Male patients.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, Egypt

Location

Related Publications (8)

• Garg R, Bhan S, Vig S. Newer regional analgesia interventions (fascial plane blocks) for breast surgeries: Review of literature. Indian J Anaesth. 2018 Apr;62(4):254-262. doi: 10.4103/ija.IJA_46_18.

  PMID: 29720750 BACKGROUND

• De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.

  PMID: 30621377 BACKGROUND

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

  PMID: 21831090 BACKGROUND

• Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.

  PMID: 10506676 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

• 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

• Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.

  PMID: 30988534 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Waleed I Hammimy, Professor

  Anaesthesiology Faculty of Medicine - Cairo University

  STUDY CHAIR

• Ahmed F Zaghlol, Assistant Professor

  Anaesthesiology Faculty of Medicine - Cairo University

  STUDY DIRECTOR

• Fatima A El Shamy, Lecturer

  Anaesthesiology National Cancer Institute - Cairo University

  STUDY DIRECTOR

• Mohhamed M Abdelrahman, M.B. B.CH

  Anaesthesiology National Cancer Institute - Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Performer of nerve blocks will know type of block but investigator for postoperative pain will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anaesthesiology, ICU and Pain Management

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: January 10, 2020
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

EG (1)