Clinical trial · Interventional
Erector Spinae Plane Block Versus Serratus Anterior Block on Post Mastectomy Pain Syndrome
Effect of Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Block on the Incidence of Post Mastectomy Pain Syndrome, Randomized Double Blinded Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Post-mastectomy Pain Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erector Spinae Plane Block | Procedure | — | UNRESOLVED |
| Serratus Anterior Plane Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Group 1 control group
- description
- Control group will recive only IV Opioids
- type
- EXPERIMENTAL
- label
- Group 2 ((Serratus Anterior Plane Block SAPB))
- description
- Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%
- interventionNames
- Procedure: Serratus Anterior Plane Block
- type
- EXPERIMENTAL
- label
- Group 3 ((Erector Spinae Plane Block ESB))
- description
- Patients will receive Ultrasound guided erector spinae plane block with injection of 30 ml levobupivacaine 0.25%.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (15)
- BACKGROUNDDe 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
- BACKGROUNDGong 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
- BACKGROUNDSmith 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
- BACKGROUNDMiguel 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
- BACKGROUNDCaffo 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
- BACKGROUNDFecho 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
- BACKGROUNDCapuco 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.