Analgesia, Breast Cancer
Conditions
Keywords
Erector spinae plane block, Ultrasound guided, Breast cancer surgery, Natural killer cells, Analgesia, spread
Brief summary
Prospective interventional study
Detailed description
The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery. The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB. The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery. Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.
Interventions
PROCEDUREErector Spinae Plane Block with Bubivacaine
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
PROCEDUREStandard General Anaesthesia
Standard General Anaesthesia without ESPB
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia \-
Exclusion criteria
1. Patient refusal. 2. Allergy or contraindication to any of the studied medications or anaesthetic agents. 3. Chronic opioid analgesic use. 4. Pregnancy. 5. Morbid obesity (BMI ≥ 40 kg/m2). 6. Scoliosis or any vertebral anomalies or previous spinal surgeries. 7. Infection at the site of injection or any other contraindication for regional anaesthesia. 8. Duration of surgery more than 90 minutes. 9. Renal impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy of ESPB | Up to 24 postoperative hours | Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spread of the injected dye in Erector Spinae plane | Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery. | 5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally). 3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded. |
| Dermatomal sensory coverage of ESPB | Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB. | will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunomodulation of ESPB | Before ESPB and 24 hours after the block. | Immunomodulation of ESPB by measuring Natural Killer cells cytotoxicity. Samples of 1 ml of patients' peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocyte populations (NK cells and cytotoxic t lymphocytes (Ctls)). CD 56 will be used as a marker for NK cells, while CD 8 will be used as a marker for Ctls. Cytotoxicity assay will be done by measuring the release of lactate dehydrogenase (LDH) from cells. Then ratio of LDH released specifically from NK cells will be correlated according to the results of flow cytometry. |
Countries
Egypt
Outcome results
None listed