Erector Spinae Plane Block Versus Serratus Anterior Block on Post Mastectomy Pain Syndrome

NCT05201963 | Completed

• 1 other identifier: AP2110-30111
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common malignancy among females. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Regionale anesthesia is one of the strategies with the potential to prevent the development of chronic pain following breast surgery. We hypothesize that erector spinae plane block is going to be more effective than serratus anterior plane block in the prevention of postmastectomy pain syndrome.

Conditions

Breast Cancer; Post-mastectomy Pain Syndrome; Acute Pain

Keywords

Breast Cancer; Post Mastectomy Pain Syndrome; Erector Spinae Plane Block; Serratus Anterior Plane Block

Outcome Measures

Primary Outcomes (1)

• Incidence of patients developing PMPS.

  Number and Percentage of patients developing PMPS

  6 months

Secondary Outcomes (13)

• Patient's Quality of life according to Flanagan Quality of Life Scale (QOLS)

  6 motnths

• Severity of PMPS according to Grading system for neuropathic pain (GSNP)

  6 motnths

• Postoperative Patient's activity level according to Barthel Activities of Daily Living Scale ADL

  6 months

• Total amount of morphine consumed postoperatively

  24 hours

• Total amount of fentanyl consumed intraoperative

  Time of surgry

Study Arms (3)

Group 1 control group

NO INTERVENTION

Control group will recive only IV Opioids

Group 2 ((Serratus Anterior Plane Block SAPB))

EXPERIMENTAL

Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%

Procedure: Serratus Anterior Plane Block

Group 3 ((Erector Spinae Plane Block ESB))

EXPERIMENTAL

Patients will receive Ultrasound guided erector spinae plane block with injection of 30 ml levobupivacaine 0.25%.

Procedure: Erector Spinae Plane Block

Interventions

Serratus Anterior Plane Block PROCEDURE

Full aseptic precautions applied. Ultrasound probe will be placed on the patient's midaxillary line in the longitudinal plane (lateral position with arm abduction), at the level of 5th rib, the indicator oriented toward the operator's left. With the rib, pleural line, overlying serratus anterior and latissimus dorsi muscles visualized, then, a 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the 5th rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be 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.6-13-MHz, linear transducer set for small parts and a depth of 1-4 cm is used for this block(15-16).

Group 2 ((Serratus Anterior Plane Block SAPB))

Erector Spinae Plane Block PROCEDURE

Full aseptic precautions applied. Ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which skin, subcutaneous tissue, trapezius and erector spinae muscle will be visible superficial to T5 transverse process. Echogenic block needle will be inserted in- plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1 ml normal saline . After aspiration to avoid intravascular injection 30 ml levobupivacaine 0.25% will be performed. 6-13-MHz, linear transducer set for small parts and a depth of 4-6 cm will be used

Group 3 ((Erector Spinae Plane Block ESB))

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• 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.
• Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Cairo Governorate, 11796, Egypt

Location

Related Publications (15)

• 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

• Gong Y, Tan Q, Qin Q, Wei C. Prevalence of postmastectomy pain syndrome and associated risk factors: A large single-institution cohort study. Medicine (Baltimore). 2020 May;99(20):e19834. doi: 10.1097/MD.0000000000019834.

  PMID: 32443289 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

• Miguel R, Kuhn AM, Shons AR, Dyches P, Ebert MD, Peltz ES, Nguyen K, Cox CE. The effect of sentinel node selective axillary lymphadenectomy on the incidence of postmastectomy pain syndrome. Cancer Control. 2001 Sep-Oct;8(5):427-30. doi: 10.1177/107327480100800506.

  PMID: 11579339 BACKGROUND

• Caffo O, Amichetti M, Ferro A, Lucenti A, Valduga F, Galligioni E. Pain and quality of life after surgery for breast cancer. Breast Cancer Res Treat. 2003 Jul;80(1):39-48. doi: 10.1023/A:1024435101619.

  PMID: 12889597 BACKGROUND

• Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.

  PMID: 19453965 BACKGROUND

• Capuco A, Urits I, Orhurhu V, Chun R, Shukla B, Burke M, Kaye RJ, Garcia AJ, Kaye AD, Viswanath O. A Comprehensive Review of the Diagnosis, Treatment, and Management of Postmastectomy Pain Syndrome. Curr Pain Headache Rep. 2020 Jun 11;24(8):41. doi: 10.1007/s11916-020-00876-6.

  PMID: 32529416 BACKGROUND

• Larsson IM, Ahm Sorensen J, Bille C. The Post-mastectomy Pain Syndrome-A Systematic Review of the Treatment Modalities. Breast J. 2017 May;23(3):338-343. doi: 10.1111/tbj.12739. Epub 2017 Jan 30.

  PMID: 28133848 BACKGROUND

• Tait RC, Zoberi K, Ferguson M, Levenhagen K, Luebbert RA, Rowland K, Salsich GB, Herndon C. Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment. J Pain. 2018 Dec;19(12):1367-1383. doi: 10.1016/j.jpain.2018.06.002. Epub 2018 Jun 30.

  PMID: 29966772 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

• 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

• 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

• Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.

  PMID: 26033127 BACKGROUND

• Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.

  PMID: 11883387 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohammed Magdy, Master

  National Cancer Institute Cairo University

  PRINCIPAL INVESTIGATOR

• Somaya Elsheikh Abdelaziz, Professor

  National Cancer Institute Cairo University

  STUDY CHAIR

• Ahmed H. Bekir, Professor

  National Cancer Institute Cairo University

  STUDY DIRECTOR

• Sayed M. Abed, Lecturer

  National Cancer Institute Cairo University

  STUDY DIRECTOR

• Mohammed ElSaed Abdelfattah, Lecturer

  National Cancer Institute Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology , ICU and Pain Management

Model Details: The patients will be randomly assigned into 3 equal groups using computer generated random numbers in opaque closed envelopes, each of which will include 40 patients. Group 1 control group N=40, Group 2 ((Serratus Anterior Plane Block SAPB)) N=40 Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25% and Group 3 ((Erector Spinae Plane Block ESB)) N=40 Patients will receive Ultrasound guided erector spinae plane block with injection of 30 ml levobupivacaine 0.25%. Randomization will be done by a statistician and each group of the patient will be revealed only when the included patient is transferred to the preanesthetic room.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 21, 2022
• Study Start: November 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

EG (1)