Comparison of fentanyl and magnesium added to levobupivacaine heavy for spinal anaesthesia in lower limb surgeries

Comparison of the effect of intrathecal fentanyl citrate and magnesium sulphate as adjuvants to hyperbaric levobupivacaine 0.5 per cent for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries A prospective randomised study - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076851

Enrollment

Registered

2024-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: S720- Fracture of head and neck of femur Health Condition 2: S723- Fracture of shaft of femur Health Condition 3: S724- Fracture of lower end of femur Health Condition 4: S721- Pertrochanteric fracture Health Condition 5: S870- Crushing injury of knee Health Condition 6: S878- Crushing injury of lower leg Health Condition 7: S820- Fracture of patella Health Condition 8: S821- Fracture of upper end of tibia Health Condition 9: S822- Fracture of shaft of tibia Health Condition

Interventions

Intervention1: levobupivacaine: levobupivacaine heavy 0.5 % 3 ml + normal saline Control Intervention1: Levobupivacaine + Fentanyl: Levobupivacaine heavy 0.5 % 3 ml + Fentanyl 25 mcg Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Patients consenting to participate in the study, aged between 18-60 years, of both sexes, of ASA grade I or II, admitted to undergo lower limb orthopaedic procedures in our institute were included in this study

Exclusion criteria

Exclusion criteria: Patients declining consent, aged less than 18 or greater than 60 years, ASA grades III or IV, suffering from any respiratory, cardiac, hepatic, renal, neurological or coagulation disorder, pregnant or already receiving opioid or magnesium therapy or having any local infection at the site of injection of spinal anaesthesia were excluded from the study.

Design outcomes

Primary

Measure	Time frame
onset and duration of sensory and motor block, duration of analgesiaTimepoint: onset of sensory and motor blockade at baseline duration of sensory blockade when the spinal block regresses till S1 (in minutes) duration of motor block till time of first mobilisation (in minutes) duration of analgesia until the patient requests rescue analgesia at VAS score greater than 3	—

Secondary

Measure	Time frame
haemodynamic parametersTimepoint: baseline, intraoperative intervals predefined at 5, 10, 15, 30, 45, 60, 90, 120 & 150 minutes;side effectsTimepoint: in the postoperative period	—

Countries

India

Contacts

Public ContactAnusha Tripathy

Gajra Raja Medical College

dr.neelimatandon21@gmail.com9826215586

Outcome results

None listed

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