A comparison of 2 medicine, for spinal anesthesia in lower limb surgeries in adult patients.

Phase 2/3

Not yet recruiting

• Conditions: Fracture of lower leg, including ankle, (2) ICD-10 Condition: S82||Fracture of lower leg, including ankle,

• Registration Number: CTRI/2025/06/088874
• Lead Sponsor: LLRM medical college

Brief Summary

This study is prospective randomized comparative study between hyperbaric levobupivacaine and hyperbaric levobupivacaine with dexmedetomidine in lower limb surgeries in adult patients under subarachnoid block. Primary objective of this study is to compare the efficacy of the drugs and to compare and evaluate the onset and duration of sensory and motor blockade in both the study groups. Hemodynamic changes- heart rate, mean arterial pressure, systolic and diastolic blood pressure. Also to compare and evaluate time of first rescue analgesia and complications if any.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

ASA grade 1 and 2, age 18-65 years of either sex, patient undergoing elective lower limb surgeries.

Exclusion Criteria

Patient refusal, ASA grade 3 and 4, known allergy or hypersensitivity to local anaesthesic drugs, infection at the injection site, bleeding diathesis or coagulopathy, pre existing ischaemic heart disease, diabetes mellitus and hypertension, CNS disorder-epilepsy and raised intracranial tension, severe renal, hepatic, hematological, metabolic disorder, cardiac malformation, spinal deformity, pregnancy, COPD, Asthma, chronic bronchitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the efficacy of the drugs	Onset of sensory and motor blockade will be assessed at different time intervals till the complete effect or for 30 minutes after injection.

Secondary Outcome Measures

Name	Time	Method
To compare and evaluate time of first rescue analgesia in both groups.	Patient to be assessed for 12 hours for rescue analgesia
Complications	Patient to be assessed for 24 hours post operatively.
Hemodynamic changes if any- heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2.	Heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2 will be recorded immediately after procedure and every 2 min for initial 10 min, every 5 min for next 30 min and at 15 min interval till completion of the surgery.
To compare and evaluate onset and duration of sensory block in both the groups, to compare and evaluate onset and duration of motor block in both groups.	Sensory and motor blockade will be evaluated every 1 minute for initial 5 min and every 2 min for next 10 min till the complete effect.

Trial Locations

Locations (1)

Lala Lajpat Rai Memorial Medical College Meerut; 🇮🇳 Meerut, UTTAR PRADESH, India

Lala Lajpat Rai Memorial Medical College Meerut

🇮🇳Meerut, UTTAR PRADESH, India

Dr Biruj Mahalia

Principal investigator

9582338327

birujmahalia7272@gmail.com