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A study to compare the characteristics of drugs- heavy ropivacaine versus levobupivacaine plus fentanyl given during spinal anaesthesia (anaesthesia technique in which drug is injected into back) in patients undergoing leg surgeries

To compare the block characteristics of intrathecal hyperbaric 0.75% ropivacaine versus 0.5% levobupivacaine plus fentanyl (25micrograms) as an adjuvant in patients undergoing lower limb surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049348
Enrollment
70
Registered
2023-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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: hyperbaric 0.75% ropivacaine plus fentanyl (25µg): To observe the block characteristics of intrathecal hyperbaric 0.75% ropivacaine plus fentanyl (25µg) as an adjuvant in patients under

Sponsors

Department of anaesthesia, PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American Society of Anesthesiologists (ASA) physical status I & II, weighing 40kg-90kg, height =150cms and are scheduled to undergo lower limb surgeries under spinal anaesthesia, who are able to understand the study protocol will be included in the study.

Exclusion criteria

Exclusion criteria: The patients who have history of allergy to local anaesthetic drug, have history of allergy to fentanyl , have any relative or absolute contraindication to spinal anaesthesia, are pregnant, have spinal deformities such as spina bifida, are not willing to give consent will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To compare- the time of onset of sensory block (T10 level with pin prick test), onset of motor block (modified bromage grade 2) & maximum sensory level achieved, time to achieve maximum motor blockade (modified bromage grade 4), total duration of sensory and motor blockade, time to demand first rescue analgesia.Timepoint: Every two minutes till 10 minutes after giving spinal anaesthesia, at 30 minutes, end of surgery, total duration of sensory and motor blockade, time to demand first rescue analgesia.—

Secondary

MeasureTime frame
To note any side effects and complications of intrathecal ropivacaine, levobupivacane and fentanyl- such as bradycardia, hypotension, respiratory depression, pruritis, nausea, vomiting, sedation etc.Timepoint: At any point of time after giving spinal anaesthesia—

Countries

India

Contacts

Public ContactDr Preeti Gehlaut

PGIMS Rohtak

preeti.gehlaut@gmail.com8950285434

Outcome results

None listed

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