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Comparision of two doses of a local anesthesia drug, named bupivacaine for pain relief in patients who undergo cardiac surgery

A comparison of effectiveness of two doses of bupivacaine for transverse thoracis muscle plane block in cardiac surgery patients: a prospective double-blind randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080053
Enrollment
24
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 0.2ml/kg of 0.25% bupivacaine: bilateral transverese thoracic muscle plane block with 0.2 ml/kg of 0.25% bupivacaine. single dose post-surgery Control Intervention1: 20 ml of 0.25% bup

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing cardiac surgeries by mid-line sternotomy. 2. Patient aged 18 years -70 years. 3. Patients with American Society of Anaesthesiologists (ASA) physical status class III and IV.

Exclusion criteria

Exclusion criteria: 1.Patient’s refusal to participate in trial. 2. allergy to bupivacine. 3. pre-operative in cardiogenic shock. 4. plan for post-operative mechanical ventilation.

Design outcomes

Primary

MeasureTime frame
To compare the total fentanyl consumption in first 24 hours after surgery in patients receiving 0.2ml/kg (actual body weight) of 0.25% bupivacaine versus 20 ml of 0.25% bupivacaine of dose of bilateral transverse thoracic muscle plane block after cardiac surgery by mid-line complete sternotomy.Timepoint: at 6,12,18 and 24 hours of surgery

Secondary

MeasureTime frame
Pain score (recorded by 0-10 Visual Analogue scale) at restTimepoint: 6,12,18 and 24 hours of surgery.;Pain score (recorded by 0-10 Visual Analogue scale) at movement/chest physiotherapyTimepoint: 6,12,18 and 24 hours of surgery.;Behavioral pain score when intubatedTimepoint: 6,12,18 and 24 hours of surgery;Short-form McGill pain questionnaire 2(SF-MPQ 4)Timepoint: 6,12,18 and 24 hours of surgery;Duration of mechanical ventilationTimepoint: at 6,12,18 and 24 hours of surgery;6. Duration of post-operative intensive unit care stay duration.Timepoint: at 6,12,18 and 24 hours of surgery;Technical difficulties if any during the procedureTimepoint: 6,12,18 and 24 hours of surgery;Complications, if any- hematoma and infection at the block siteTimepoint: 6,12,18 and 24 hours of surgery

Countries

India

Contacts

Public ContactAvneet Singh

Government Medical College and Hospital,Chandigarh

avneetsinghhch@gmail.com9431105840

Outcome results

None listed

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