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Comparision of effects of 3 drugs Bupivacaine, Levobupivacaine, Ropivacaine on heart rhythm

Comparative study of effects of Bupivacaine Vs Levobupivacaine Vs Ropivacaine on myocardial conduction system as assessed by P wave dispersion, QT & QTc interval in lower limb orthopaedic surgeries using Holter Monitoring. - BULERO-CARD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/09/015812
Enrollment
75
Registered
2018-09-24
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: M169- Osteoarthritis of hip, unspecified Health Condition 2: M161- Unilateral primary osteoarthritisof hip Health Condition 3: S729- Unspecified fracture of femur Health Condition 4: S829- Unspecified fracture of lower leg

Interventions

Control Intervention1: Bupivacaine: Bupivacaine is a highly lipophilic amide compound which is commonly prepared as a racemic mixture of R(+) and S(-) isomers. However, it is associated with side effe

Sponsors

DR Ram Manohar Lohia Institute Of Medical Sciences
Lead Sponsor
DR Ram Manohar Lohia Institute Of Medical Science
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with ASA physical status I-II 2. Age 18-65 years of either sex 3. Elective lower limb orthopaedic surgeries

Exclusion criteria

Exclusion criteria: 1. Patient refusal to give consent. 2. Patients with hypersensitivity to amide local anesthetics. 3. Pregnant patients. 4. Patients having raised ICP, neurological or neuromuscular diseases. 5. Patients with congenital spinal anomalies, scoliosis, post-traumatic vertebral injuries. 8. Patients with cardiovascular diseases, severe renal diseases, hepatic diseases or respiratory diseases. 9. Patients with severe hypovolaemia, hemorrhagic and hypovolemic shock, severe anemia, bleeding coagulopathy and Systemic or local infection. 10. Patients either on antiarrhythmic drugs or any other drugs which are known to cause alteration in myocardial conduction system.

Design outcomes

Primary

MeasureTime frame
Change in PR, QT, QTc intervalTimepoint: before induction,every 10 minutes after epidural loading for 1 hour then every 30 minutes till completion of surgery then every 4hourly for 24 hours

Secondary

MeasureTime frame
change in heart rate and blood pressureTimepoint: before induction,every 10 minutes after epidural loading for 1 hour then every 30 minutes till completion of surgery then every 4hourly for 24 hours

Countries

India

Contacts

Public ContactVaishali Agrawal

DR.Ram Mnohar Lohia Institute

drdas_73@rediffmail.com7275068939

Outcome results

None listed

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