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A CLINICAL STUDY TO COMPARE THE EFFICACY OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK OVER THORACIC EPIDURAL FOR PAIN RELIEF IN PATIENTS UNDERGOING BREAST SURGERY

A PROSPECTIVE RANDOMIZED PARALLEL ARM SINGLE BLINDED CLINICAL STUDY TO COMPARE THE EFFICACY OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK OVER THORACIC EPIDURAL FOR PERIOPERATIVE ANALGESIA IN PATIENTS UNDERGOING MODIFIED RADICAL MASTECTOMY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029736
Enrollment
42
Registered
2020-12-11
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: Ultrasound Guided Erector Spinae Plane BLock: In Group E, patients will recieve Ultrasound guided Erector Spinae Plane block with 20 ml of 0.25% Bupivacaine Control Intervention1: Thora

Sponsors

Deepshikha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I - III Those scheduled for unilateral modified radical mastectomies and breast conservation surgeries

Exclusion criteria

Exclusion criteria: Anomalies of the vertebral column Blood/ CSF tap during the procedure Failed blocks Patients with coagulation disorders / on anticoagulants Patients with thrombocytopenia platelet count less than 1 lakh/mm3 Infection at injection site H/O previous mastectomy surgery BMI > 35 kg/m2 Allergy to local anesthetic

Design outcomes

Primary

MeasureTime frame
Intraoperative Fentanyl consumption and postoperative pain scores immediately after extubation, at 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs after extubation Duration between extubation and demand of first rescue analgesic Timepoint: Intraoperative Fentanyl consumption and postoperative pain scores immediately after extubation, at 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs after extubation. Duration between extubation and demand of first rescue analgesic—

Secondary

MeasureTime frame
Monitoring of haemodynamic changes Monitoring of post operative nausea and vomiting Timepoint: Haemodunamic changes every 10 minutes intraoperatively and immediately sfter extubation , at 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs after extubation. Post operative Nausea and vomiting immediately after extubation, at 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs after extubation—

Countries

India

Contacts

Public ContactDeepshikha

Sri Ramachandra University

reetharun@gmail.com9840529863

Outcome results

None listed

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