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Effect of Ketorolac of VEGF and TGF-B release in breast cancer resection surgery.

Effect Of Intraoperative Single Dose Ketorolac On Release Of Vegf And Tgf-Î? In Patients Undergoing Breast Cancer Resection â?? A Prospective Randomized Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034467
Enrollment
100
Registered
2021-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: IV ketorolac: Group 1 â?? will receive intravenous (I.V.) ketorolac Dose - 30 mg, single dose just before incision. Control Intervention1: Group 2 - saline placebo: will receive 1 ml

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. > 18 years 2. Posted for MRM, lumpectomy or BCS. 3. ASA I to III

Exclusion criteria

Exclusion criteria: 1. Not consenting for study. 2. Bilateral breast surgery 3. Allergic to use of NSAIDâ??s 4. Weight 100 kg. 5. Renal dysfunction, history of upper GI bleed, bleeding diathesis. 6. History of invasive cancer in last 5 years. 7. Chronic use of NSAIDâ??s for other painful conditions 8. Patients received neoadjuvant chemotherapy (NACT) before surgery

Design outcomes

Primary

MeasureTime frame
1) Evaluate the effect of single dose of perioperative ketorolac 30 mg (given before incision) on levels of marker predictive of tumour spread and metastasis â?? VEFF. 2) To evaluate the effect of Ketorolac on other markers of tumour spread i.e. TGF-β, NLR and PLR (platelet lymphocyte ratio) in patients undergoing curative breast cancer resection. Timepoint: baseline - before incision intaroperative - after tumour resection post-operative - 24 hours after surgery—

Secondary

MeasureTime frame
1. To compare recurrence free survival (RFS) at two years of follow up in patients undergoing breast cancer resection. 2. Calculate the overall survival (OS) â?? defined as time from date of surgery rill death or last follow up. 3. Effect of single dose ketorolac on perioperative analgesic requirement â?? record the intra-operative and post-operative fentanyl consumption. 4. Adverse effects â?? surgical site bleeding/haematoma/seroma. Timepoint: 1. follow up for RFS - 6 monthly follow up till 2 years after surgery ( total of 4 follow ups). 2. analgesic requirements and complications - for first 24 hours after surgery.—

Countries

India

Contacts

Public ContactSaurabh vig

National Cancer Institute, All India Institute of Medical Sciences.

saurabh377@yahoo.com9538247725

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026