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Comparing the Effects of Single vs. Multiple Doses of Spinal Anesthesia for Lower Limb Surgery

Comparison of bolus dose versus fractionated dose of hyperbaric bupivacaine and fentanyl in spinal anaesthesia among adult patients undergoing lower limb surgery - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082060
Enrollment
90
Registered
2025-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Hyperbaric Bupivacaine (0.5%) + Fentanyl (25 mcg) Fractionated Dose: Dose: 2.5 ml (12.5 mg) of Bupivacaine + 0.5 ml (25 mcg) of Fentanyl Frequency
Single administration Route of Administration: Intrathecal (spinal anesthesia) Duration of Therapy: Given as a fractionated dose,2 ml of the total dose injected initially, followed by the remaining 1

Sponsors

Christian Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient who give informed consent. 2. ASA (American Society of Anaesthesiologists) I & II[ANNEXURE1] 3. All men and women 4. Adult 18-60 years 5. Elective lower limb surgeries under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients with significant neurological deficit. 2. Spinal column deformities. 3. Patients on anticoagulants. 4. Allergic to local anaesthetic. 5. Allergic to adjuvant drug. 6. Patient with any skin lesion at the injection site.

Design outcomes

Primary

MeasureTime frame
1. To compare the effects on haemodyamic parameters on patient receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine and fentanyl. Timepoint: Hemodynamic Trends (HR, SBP, DBP, MAP, SpO2)-Baseline (before spinal anesthesia), then intraoperatively at 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min, 40 min, 50 min, 60 min, 70 min, 80 min, 90 min, 100 min, 110 min, and 120 min. Postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.—

Secondary

MeasureTime frame
To compare block characteristics & post operative analgesia in patients receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine & fentanyl.Timepoint: Sensory & Motor Block Characteristics-Every 5 minutes intraoperatively until maximum block is achieved, then postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours. Duration of Postoperative Analgesia- Postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.—

Countries

India

Contacts

Public ContactDr Manavdeep Singh

Christian Medical College and Hospital

manav1196@gmail.com9915381178

Outcome results

None listed

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