A prospective double blind randomised clinical trial for comparison of heavy Ropivacaine with Morphine and heavy Levobupivacaine with Morphine for sub arachnoid block in lower limb surgeries.

A Prospective randomised Double Blind Clinical Trial for Comparison of 0.75% Ropivacaine heavy with Morphine and 0.5% Levobupivacaine heavy with Morphine for Sub-Arachnoid block in Lower Limb Surgeries. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092210

Enrollment

Registered

2025-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Group R: Group R received intrathecal dose of 3ml 0.75% Heavy Ropivacaine along with 200mcg Morphine total of 3.2ml Control Intervention1: Group L: Group L received intrathecal dose

Eligibility

Inclusion criteria

Inclusion criteria: ASA Class 1, 2 BMI less than 40 Elective Lower limb surgeries.

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Patients with significant coagulopathies and other contra-indications for sub arachnoid block. 3. Patients with any pre existing neurological deficit in lower part of the body. 4. Patients allergic to the drugs used in the study. 5. Duration of surgery more than 120 minutes.

Design outcomes

Primary

Measure	Time frame
To compare the onset and duration of sensory and motor blockadeTimepoint: Sensory block: Will be assessed by checking for loss of pin prick, using 22- gauge hypodermic needle sensation every 1 min till the onset of loss of sensation till highest level is achieved, then every 30min in the post operative period till regression of loss of sensation upto S2. Motor block will be assessed every 1 min till loss of lower limb movements or bromage 3 is achieved then every 30mins till lower limb movements are regained or bromage 0 achieved in post operative period	—

Measure

Time frame

To compare the onset and duration of sensory and motor blockadeTimepoint: Sensory block: Will be assessed by checking for loss of pin prick, using 22- gauge hypodermic needle sensation every 1 min till the onset of loss of sensation till highest level is achieved, then every 30min in the post operative period till regression of loss of sensation upto S2. Motor block will be assessed every 1 min till loss of lower limb movements or bromage 3 is achieved then every 30mins till lower limb movements are regained or bromage 0 achieved in post operative period

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Secondary

Measure	Time frame
To compare the hemodynamic changes and adverse effects between the two groupsTimepoint: Saturation, non-invasive blood pressure and heart rate will be monitored at 3 minutes interval for first 15minutes post injection and at 5 minutes intervals thereafter till 1 hour after which assessment was performed every 10 min interval till end of surgery and then at 30 min intervals thereafter until complete recovery of sensations and motor blockade of grade 0 on Bromage scale will be observed.	—

Measure

Time frame

To compare the hemodynamic changes and adverse effects between the two groupsTimepoint: Saturation, non-invasive blood pressure and heart rate will be monitored at 3 minutes interval for first 15minutes post injection and at 5 minutes intervals thereafter till 1 hour after which assessment was performed every 10 min interval till end of surgery and then at 30 min intervals thereafter until complete recovery of sensations and motor blockade of grade 0 on Bromage scale will be observed.

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Countries

India

Contacts

Public ContactDr Pavan Dhulkhed

SDM College of Medical Sciences and Hospital Dhawad

pavandhulkhed1984@gmai.com8150885678

Outcome results

None listed

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