Health Condition 1: null- Adult females more than 18 years age, with breast cancer scheduled to undergo unilateral partial or complete mastectomy with and without axillary dissection for breast cancer surgery (T1-3, N0-2, M0) Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Paravertebral block group: After routine monitoring, premedication with midazolam (1-1.5mg) and fentanyl (25mcg boluses),cleaning and draping the back, the spinous processes of T1-T6 sp
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Female patients, > 18 years, ASA physical status I-III patients with early or locally advanced breast cancer scheduled to undergo unilateral partial or complete mastectomy with and without axillary dissection or implant insertion for breast cancer surgery (T1-3, N0-2, M0)
Exclusion criteria
Exclusion criteria: 1.Patientââ?¬•s refusal 2.Any contraindications to regional anaesthesia (coagulopathy iatrogenic or genetic, infection at site of block, allergy to local anaesthetics 3.Previous surgery in the paravertebral region, vertebral anomalies such as scoliosis 4.Patients with BMI >30 kg/m2 will also not be included in the study. 5.Patients with history of any other type of cancer in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess Quality of life using EORTC questionnaire QLQC-30.Timepoint: At baseline (prior to surgery) and at 2 weeks following surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.In addition other quality of life questionnaires will be administered: a.The WHO-QoL BREF b.EORTC QLQ-BR23 c.FACT B4 questionnaire 2.To assess the Quality of recovery using the QoR-40. 3.Anxiety and Depression using the DASS scale. 4.The circulating tumour cells (CTCs). 5.Acute pain will be measured using a 0-100 visual analogue scale (VAS). 6.Chronic pain will be assessed using Chronic Pain and symptom score.Timepoint: 1a,1b,1c and 3: baseline (prior to surgery)and at 2weeks following surgery. 2.QoR-40 at 24 hours postoperatively. 4.CTCs to be measured pre and immediate post operatively. 5.Pain assessment (VAS) at 1, 2, 4, 6, 12 and 24 hours postoperatively. 6.Chronic pain will be assessed at 12-14 weeks following surgery. All the postoperative questionnaires can be administered telephonically (video or audio call) in case patient is unable to physically come to the hospital. | — |
Countries
India
Contacts
Public ContactAnjolie Chhabra
All India Institue of Medical Sciences
Outcome results
None listed