Randomized comparative study to evaluate safety of levobupivacaine and ropivacaine in patients posted for TURP

A Randomized Comparative Study to Evaluate The Effects and Safety of Intrathecal Hyperbaric Levobupivacaine 0.5% and Hyperbaric Ropivacaine 0.75% In Patients Undergoing Transurethral Resection of Prostate(TURP) Surgery under Spinal Anaesthesia - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063349

Enrollment

Registered

2024-02-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Spinal anaesthesia group A: Spinal anaesthesia for patient undergoing TURP with hyperbaric LEVOBUPIVACAINE 0.5% with dose of 3ml (15mg) and monitoring of vitals throughout the surgery C

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and ASA 2 patients posted for TURP

Exclusion criteria

Exclusion criteria: 1. Negative consent by the patient 2. Contraindication for spinal Anaesthesia (such as coagulopathy, infection at injection site, hypotension, disease or deformity of spine) 3. Psychiatric patient 4. ASA status III/IV 5. Known sensitivity to the drug

Design outcomes

Primary

Measure	Time frame
The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine.Timepoint: Outcomes will be assessed at baseline, time intervals of 2min upto 10min after administration of spinal anaesthesia with the selected drugs followed by every 5 minutes until completion of surgery	—

Measure

Time frame

The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine.Timepoint: Outcomes will be assessed at baseline, time intervals of 2min upto 10min after administration of spinal anaesthesia with the selected drugs followed by every 5 minutes until completion of surgery

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactSapna Bansal

MMIMSR, Mullana

drsapna10@gmail.com8168381441

Outcome results

None listed

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