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In adult patients undergoing lower limb orthopaedic surgeries planned under spinal anesthesia comparing ropivacaine with fentanyl as an additive and bupivacaine with fentanyl as an additive in terms of effectiveness and working power

A Randomised Double-blind Controlled trial to compare the efficacy and safety profile of intrathecal 0.75 percentage Ropivacaine-Fentanyl 50mcg and 0.5 percentage Bupivacaine-Fentanyl 50mcg in adult patients undergoing lower limb orthopedic surgeries in a rural tertiary care hospital. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109828
Enrollment
104
Registered
2026-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: S828- Other fractures of lower leg Health Condition 2: S728- Other fracture of femur Health Condition 3: S920- Fracture of calcaneus Health Condition 4: S820- Fracture of patella Health Condition 5: S720- Fracture of head and neck of femur Health Condition 6: S822- Fracture of shaft of tibia Health Condition 7: S825- Fracture of medial malleolus Health Condition 8: S921- Fracture of talus Health Condition 9: S824- Fracture of shaft of fibula Health Condition 10: S722- Subtroc

Interventions

Intervention1: Intrathecal 0.75% Ropivacaine-Fentanyl 50mcg: Intrathecal anaesthesia with 0.75% Ropivacaine-Fentanyl 50mcg to make final volume of 3.6ml will be given to adult patients undergoing lowe

Sponsors

Mahatma Gandhi Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.American Society of Anaesthesiologists Grade I and II patients. 2.Age group of 18-65 years of any gender. 3.Height is more than 4 feet. 4.Patients scheduled for elective lower limb orthopaedic surgeries. 5.Patients willing to take part in the study.

Exclusion criteria

Exclusion criteria: 1.American Society of Anaesthesiologists Grade III and IV patients. 2.Patients refusing to voluntarily participate in the study. 3.Patients with known contraindications for spinal anaesthesia: bleeding disorders, local infection. 4.Patients with hemodynamic instability. 5.Patient with allergy to or history of hypersensitivity to local anaesthetic. 6.Pregnant/Lactating women. 7.Patients with opioid tolerance.

Design outcomes

Primary

MeasureTime frame
Time required for first rescue analgesiaTimepoint: 24 hours—

Secondary

MeasureTime frame
Haemodynamic stability, sensory and motor blockTimepoint: 3 hours—

Countries

India

Contacts

Public ContactDr UNNATI PURUSHOTTAM MAMULKAR

MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, SEWAGRAM, WARDHA

dhirajbhandari@mgims.ac.in9970195086

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026