A clinical trial of study the effect of two drug(levobupivacaine and ropivacaine) with dexmedetomidine in lower limb surgeries under epidural anaesthesia

Comparative study of Levobupivacaine versus Ropivacaine with Dexmedetomidine in lower limb surgeries under Epidural. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084714

Enrollment

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: - Health Condition 2: S829- Unspecified fracture of lower leg

Interventions

Intervention1: Epidural anaesthesia: Epidural Anaesthesia under aseptic condition ,L3-L4 OR L4-L5 interspace will be identified in sitting position 18G touhy neddle guided slowly untill epidural spa

Eligibility

Inclusion criteria

Inclusion criteria: all lower limb elective sugery in asa 1 and asa 2 BMI less than 30

Exclusion criteria

Exclusion criteria: patients refusal pregnant women BMI more than 30 contraindication of epidural anaesthesia previous surgery of spine allergy to study drug asa 3 ad asa 4

Design outcomes

Primary

Measure	Time frame
Comparison of Block Characteristics in Terms of Time Taken for Onset of Sensory and Motor Block and Duration of Sensory and Motor BlockTimepoint: Assess the Heart Rate, Blood Pressure, Oxygen Saturation, and MAP i.e. Will be Monitored Every 3 mins for First 15 mins, Every 5 mins Until 60 mins Into Surgery, Every 10 mins Until the End of Surgery, Every hour Until the Patient Experiences Post-Operative Pain.	—

Measure

Time frame

Comparison of Block Characteristics in Terms of Time Taken for Onset of Sensory and Motor Block and Duration of Sensory and Motor BlockTimepoint: Assess the Heart Rate, Blood Pressure, Oxygen Saturation, and MAP i.e. Will be Monitored Every 3 mins for First 15 mins, Every 5 mins Until 60 mins Into Surgery, Every 10 mins Until the End of Surgery, Every hour Until the Patient Experiences Post-Operative Pain.

—

Secondary

Measure	Time frame
Comparison of analgesic effect in terms of: Time taken for first rescue analgesia Intraoperative hemodynamic changes Adverse effects, if anyTimepoint: modified bromage scale at when drug given every three minute for first fiffteen minute and every five minute till to sixty minute and every ten minute till end of surgery every hour till first experience of pain in post operative adverse effect if any	—

Measure

Time frame

Comparison of analgesic effect in terms of: Time taken for first rescue analgesia Intraoperative hemodynamic changes Adverse effects, if anyTimepoint: modified bromage scale at when drug given every three minute for first fiffteen minute and every five minute till to sixty minute and every ten minute till end of surgery every hour till first experience of pain in post operative adverse effect if any

—

Countries

India

Contacts

Public ContactVivek Tomar

Hind Institute of Medical Sciences

shamshir.s66@gmail.com9140448014

Outcome results

None listed

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