Clinical trial · Interventional
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
NCT04860115CI-TRIAL-00054124unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Markers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Block group
- description
- Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
- interventionNames
- Procedure: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.
Primary outcomes (1)
- measure
- Difference in NLR
- timeFrame
- 24 hours after surgery
- description
- Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy. * Older than 18 years * ASA I-III Exclusion Criteria: * Weight \< 50 kg * BMI \> 35 * Allergy to local anaesthetic or dexmetomidine * Contraindications to NSAIDs use * Local infection over block site * Coagulopathy * Preexisting chronic pain * Pregnancy * Autoimmune disease * Inability to give informed consent
References
Publications (19)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
- 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
- BACKGROUNDAndersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24. PMID 21435953
- BACKGROUNDLee SK, Choi MY, Bae SY, Lee JH, Lee HC, Kil WH, Lee JE, Kim SW, Nam SJ. Immediate postoperative inflammation is an important prognostic factor in breast cancer. Oncology. 2015;88(6):337-44. doi: 10.1159/000368985. Epub 2015 Feb 25. PMID 25721153
- BACKGROUNDDuff S, Connolly C, Buggy DJ. Adrenergic, Inflammatory, and Immune Function in the Setting of Oncological Surgery: Their Effects on Cancer Progression and the Role of the Anesthetic Technique in their Modulation. Int Anesthesiol Clin. 2016 Fall;54(4):48-57. doi: 10.1097/AIA.0000000000000120. No abstract available. PMID 27648890
- BACKGROUNDFreise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4. PMID 22058144
- BACKGROUNDKlein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026. PMID 10825328
- Kolawole IK, Adesina MD, Olaoye IO. Intercostal nerves block for mastectomy in two patients with advanced breast malignancy. J Natl Med Assoc. 2006 Mar;98(3):450-3.