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comparsion of bupivacine heavy with fentanyl and ropivacine heavy with fentanyl for spinal anaesthesia

A Randomized prospective study for clinical comparsion of intrathecal hyperbaric bupivacaine with fentanyl versus intrathecal hyperbaric ropivacine with fentanyl for patients undergoing orthopedic lowerlimb surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051449
Enrollment
117
Registered
2023-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: Bupivacaine with Fentanyl,: 3 ml of 0.5% Bupivacaine (H) with 0.5 ml fentanyl under SA FOR SURGERY LASTING UPTO 180 MINS Intervention2: Ropivacaine with fentanyl: 3 ml of 0.75% ropivaca

Sponsors

Dr Meenakshi Telang
Lead Sponsor
Subharti Medical College
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: ASA GRADE 1 & 2, WEIGHING 55-85 KG SCHEDULED FOR ELECTIVE ORTHOPEDIC LOWER LIMB SURGERY.

Exclusion criteria

Exclusion criteria: 1. Uncooperative patient. 2. Refusal to technique or enrolment for study. 3. Known hypersensitivity to study drugs or using any drug that modifies pain perception. 4. Deformity/Abnormality of spinal column. 5. Infection at site of lumbar puncture. 6. Patients with physical status of ASA grade III or greater. 7. Patients with history of severe cardiac or pulmonary disease, poorly controlled hypertension. 8. Morbidly obese patients, neurologic or psychological disease, hepatic or renal dysfuction, endocrinal or metabolic disorders. 9. Bleeding or coagulation disorder.

Design outcomes

Primary

MeasureTime frame
1.To evaluate and compare the onset and duration of sensory and motor blockade after intrathecal bupivacaine heavy with fentanyl and intrathecal ropivacaine heavy with fentanyl. 2.To evaluate and compare the time taken for two dermatome sensory regression to S1 after intrathecal administration of bupivacaine with fentanyl and ropivacaine with fentanyl. 3.To compare the post op analgesia. 4.To evaluate and compare the hemodynamic changes of systemic BP and HR.Timepoint: immediate postop, 1st 30 mins postop, 1 hour postop, 2 hours postop, 3 hours postop, 4 hours postop, 5 hours postop, 6 hours postop

Secondary

MeasureTime frame
1. To determine any side effects due to Bupivacaine, Ropivacaine or Fentanyl during the study period.Timepoint: 1 hour post operatively

Countries

India

Contacts

Public ContactDr Meenakshi Telang

Swami Vivekanand Subharti University

drsumitsalonyagarwal@gmail.com9557038599

Outcome results

None listed

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