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Comparison Between Intrathecal Isobaric Bupivacaine Hydrochloride Versus Hyperbaric Bupivacaine Hydrochloride

Comparison Between Intrathecal 0.5 Percent Isobaric Bupivacaine Hydrochloride Versus 0.5 Percent Hyperbaric Bupivacaine Hydrochloride With Fentanyl As An Adjuvant In Both For Proximal Femur Nailing Surgery A Prospective Randomized Double Blind Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095440
Enrollment
70
Registered
2025-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: S721- Pertrochanteric fracture Health Condition 2: S722- Subtrochanteric fracture of femur

Interventions

Intervention1: Isobaric Bupivacaine 0.5 Percent With Fentanyl: Single Injection Spinal Anaesthesia Of 0.5 Percent Isobaric Bupivacaine 2.5ml 12.5mg With 0.5ml 25mcg Fentanyl Total Volume 3 ml given On

Sponsors

Pacific Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients of age group between 50 and 70 years of either sex Patient belonging to American Society of Anesthesiologists ASA grade I and II Patients posted for Proximal Femoral Nailing surgery Patients who required elective surgery only

Exclusion criteria

Exclusion criteria: Patient refusal for the procedure and technical difficulties Age less than 50 and more than 70 years ASA Grade More Than III Patients with known hypersensitivity to Bupivacaine Fentanyl Mental retardation congenital anomaly patients Those with bleeding disorders and local sepsis

Design outcomes

Primary

MeasureTime frame
We will compare the efficacy of both hyperbaric and isobaric preparations of bupivacaine and if possible to replace hyperbaric bupivacaine with fentanyl with isobaric bupivacaine with fentanyl specially in elderly patients due to its superior hemodynamic stability postoperative analgesia and recoveryTimepoint: Onset of sensory and motor block Duration of sensory and motor block Hemodynamic changes at 0,5,10,15,20,25,30,60,90 Minutes—

Secondary

MeasureTime frame
Efficacy of postoperative analgesia Side effects (Bradycardia, Respiratory Depression, hypotension, nausea & vomiting, shivering) Timepoint: Efficacy Of Postoperative Analgesia Was Assessed At 30 Minutes, 1, 2, 4, And 8 Hours Along With The Need For Rescue Analgesia. Side Effects Such As Bradycardia, Respiratory Depression, Hypotension, Nausea And Vomiting, And Shivering Were Observed And Recorded For 24 Hours.—

Countries

India

Contacts

Public ContactDr Swati Sharma

Pacific Medical College Hospital

28ganesha@gmail.com9372985559

Outcome results

None listed

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