A study comparing two medicines (bupivacaine and ropivacaine) used for spinal anesthesia in patients undergoing surgery, to see which works better and is safer

A comparative study between hyperbaric ropivacaine and hyperbaric bupivacaine for spinal anaesthesia in infra-umbilical surgeries in a tertiary care centre in Manipur - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095861

Enrollment

104

Registered

2025-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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 Ropivacaine 0.75%: 3 mL (22.5 mg) administered intrathecally (subarachnoid block) as a single dose before surgery, using standard spinal anesthesia technique at L3 L4 intersp

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18 and 65 years ASA (American Society of Anesthesiologists) physical status I or II Scheduled for elective infraumbilical surgeries (e.g., inguinal hernia repair, hydrocelectomy, gynecological procedures, lower limb orthopedic surgeries) Patients who provide written informed consent

Exclusion criteria

Exclusion criteria: Known hypersensitivity to local anesthetics of the amide group History of coagulopathy or on anticoagulant therapy Local infection at the puncture site History of spinal deformities, previous spinal surgery, or neurological disorders Pregnant or lactating women Patients on medications that may interact with local anesthetics Severe cardiovascular, hepatic, or renal disease

Design outcomes

Primary

Measure	Time frame
Duration of sensory and motor block following spinal anesthesia with hyperbaric bupivacaine versus ropivacaine.Timepoint: Baseline (before spinal block) At regular intraoperative intervals (every 5 minutes for the first 30 minutes, then every 15 minutes until block regression) At the time of complete recovery from sensory and motor bloc	—

Secondary

Measure	Time frame
Duration of effective analgesia, hemodynamic stability including heart rate & blood pressure, & incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, shivering, & pruritus.Timepoint: From intrathecal injection to twenty-four hours postoperatively, with hemodynamic parameters assessed every five minutes for the first thirty minutes, every ten minutes until the end of surgery, & in the post-anesthesia care unit; adverse effects assessed intraoperatively & up to twenty-four hours postoperatively.	—

Measure

Time frame

Duration of effective analgesia, hemodynamic stability including heart rate & blood pressure, & incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, shivering, & pruritus.Timepoint: From intrathecal injection to twenty-four hours postoperatively, with hemodynamic parameters assessed every five minutes for the first thirty minutes, every ten minutes until the end of surgery, & in the post-anesthesia care unit; adverse effects assessed intraoperatively & up to twenty-four hours postoperatively.

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Countries

India

Contacts

Public ContactThoudam Chandish Singh

Shija Hospitals and Research Institute

drthdinesh@gmail.com9863122865

Outcome results

None listed

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