A Clinical trial to study the effects of two drugs, levobupivcaine alone and levobupivacaine with dexmedetomidine, in patients undergoing lower limb surgery.

Efficacy of 0.5 percent Levobupivicaine versus 0.5 percent Levobupivicaine with Dexmedetomidine in lower limb surgeries under spinal anaesthesia : A prospective randomized double blinded study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079504

Enrollment

120

Registered

2025-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: PCS- Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 0.5% LEVOBUPIVICAINE: To see the effect of intrathecal administration of 0.5% LEVOBUPIVICAINE 3ml on onset, duration of sensory and motor block

haemodynamic alterations and duration of post operative analgesia. Control Intervention1: DEXMEDETOMIDINE: To see the effect of intrathecal administration of DEXMEDETOMIDINE 5mcg along with 0.5% LEVO

haemodynamic alterations and duration of post operative analgesia.

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing orthopaedic lower limb surgeries Patients under ASA 1 and 2

Exclusion criteria

Exclusion criteria: Patients known allergic to local anaesthetic agents Patients having raised ICP Patients having chronic kidney disease/acute kidney disease Platelet and coagulation disorders Spine deformities or skin infection at local sites Pregnant patients Patient having sinus bradycardia

Design outcomes

Primary

Measure	Time frame
To compare the effect of intrathecal administration of Dexmedetomidine on the onset and duration of sensory and motor block with Levobupivacaine versus Levobupivacaine alone.Timepoint: at baseline, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 25 minutes, 40 minutes, 55 minutes,70 minutes, 85 minutes, 100 minutes, 115 minutes, 130 minutes, 145 minutes, 160 minutes, 175 minutes, 190 minutes.	—

Measure

Time frame

To compare the effect of intrathecal administration of Dexmedetomidine on the onset and duration of sensory and motor block with Levobupivacaine versus Levobupivacaine alone.Timepoint: at baseline, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 25 minutes, 40 minutes, 55 minutes,70 minutes, 85 minutes, 100 minutes, 115 minutes, 130 minutes, 145 minutes, 160 minutes, 175 minutes, 190 minutes.

—

Secondary

Measure	Time frame
To compare the haemodynamic alterations & duration of post operative analgesia of levobupivacaine with dexmedetomidine & levobupivacaine alone.Timepoint: at baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes & 180 minutes	—

Countries

India

Contacts

Public ContactRajashree Devi

IMS AND SUM Hospital

swarnabanerjee@soa.ac.in9437341397

Outcome results

None listed

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