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In adult patients undergoing lower limb orthopaedic surgeries, planned under spinal anesthesia comparing buprenorphine versus fentanyl as an additive to 0.75% ropivacaine, in terms of effectiveness and working power

A Prospective Randomized double-blind controlled study to compare efficacy of intrathecal Buprenorphine versus Fentanyl as adjuvant to 0.75% Ropivacaine in adult patients undergoing lower limb orthopaedic surgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109598
Enrollment
70
Registered
2026-04-28
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: S72- Fracture of femur Health Condition 2: S820- Fracture of patella Health Condition 3: S722- Subtrochanteric fracture of femur Health Condition 4: S920- Fracture of calcaneus Health Condition 5: S828- Other fractures of lower leg

Interventions

Intervention1: 60mcg buprenorphine as adjuvant with 0.75% Ropivacaine: 60mcg buprenorphine as adjuvant with 0.75% Ropivacaine to form total drug volume of 3.6ml for spinal anaesthesia single time in a

Sponsors

Mahatma Gandhi Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.American Society of Anesthesiologists Grade I and II patients 2.Adult patients aged more than 18 years of either gender 3.Patients undergoing lower limb orthopedic surgeries 4.Height is more than 4 feet

Exclusion criteria

Exclusion criteria: 1.American Society of Anesthesiologist Grade III and IV patients 2.Patients with known contraindications for spinal anesthesia: bleeding disorders, local 3.Infection. 4.Patients with hemodynamic instability. 5.Patients with allergy to or history of hypersensitivity to local anesthetics. 5.Patients with comorbidities like uncontrolled hypertension,diabetes mellitus,cardiac diseases, etc. 6.Emergency surgeries 7.Patients with known allergy to opioids 8.Patients refusal 9.Patients with a history of severe PPDH or PONV after spinal anaesthesia 10.Joint replacement surgery 11.Orthopedic surgeries which are anticipated to be requiring prolonged duration of action more than 90 minutes that will require supplementation with epidural catheterization or general anesthesia

Design outcomes

Primary

MeasureTime frame
The duration of sensory and motor blockadeTimepoint: 2-4 hour—

Secondary

MeasureTime frame
Hemodynamic stability,sensory and motor blockTimepoint: 3 hour—

Countries

India

Contacts

Public ContactDr MAYUR CHANDRASHEKHAR TIDKE

MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES,SEVAGRAM,WARDHA

dhirajbhandari@mgims.ac.in9970195086

Outcome results

None listed

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