A comparative study of heavy ropivacaine 0.75% with heavy bupivacaine 0.5% in spinal anaesthesia for below umbilical surgeries.

A prospective randomized comparative study of hyperbaric ropivacaine 0.75% versus hyperbaric bupivacaine 0.5% in spinal anaesthesia for elective infraumbilical surgeries

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052606

Enrollment

Registered

2023-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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: 0.75% Hyperbaric Ropivacaine: Group R : 2.6ml of 0.75% hyperbaric ropivacaine Administered Intrathecally at the start of procedure Duration of action : 3 hours Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective infraumbilical or lower limb surgery under spinal anaesthesia. 2. Who belong to American Society of Anesthesiologists Physical Status I or II will be included in the study.

Exclusion criteria

Exclusion criteria: â?¢ Patient refusal â?¢ Infection at the site of injection â?¢ Uncorrected hypovolemia â?¢ Allergy â?¢ Increased intracranial pressure â?¢ Coagulopathy â?¢ Sepsis â?¢ Fixed cardiac output states â?¢ Indeterminate neurological disease â?¢ Patients in altered mental status â?¢ Pregnant females.

Design outcomes

Primary

Measure	Time frame
1.Time taken for onset of sensory and motor blockade. 2.Time to achieve maximum sensory level. 3.Time for 2-segment regression. 4.Time taken for sensory and motor recovery. Timepoint: 1.Sensory blockade immediately after administering spinal anaesthesia ( baseline ) followed by every 2 min from baseline until T10 block achieved 2.Motor blockade at Baseline followed by every 2 min from baseline till bromage scale - 3 or complete motor blockade achieved. 3.Sensory level will be checked at baseline followed by every 5 minutes from baseline thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression	—

Measure

Time frame

1.Time taken for onset of sensory and motor blockade. 2.Time to achieve maximum sensory level. 3.Time for 2-segment regression. 4.Time taken for sensory and motor recovery. Timepoint: 1.Sensory blockade immediately after administering spinal anaesthesia ( baseline ) followed by every 2 min from baseline until T10 block achieved 2.Motor blockade at Baseline followed by every 2 min from baseline till bromage scale - 3 or complete motor blockade achieved. 3.Sensory level will be checked at baseline followed by every 5 minutes from baseline thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression

—

Secondary

Measure	Time frame
Mean change in vital parameters (heart rate, blood pressure , respiratory rate, oxygen saturation) Frequency of adverse events Timepoint: 1.Blood pressure will be recorded at baseline ( immediately after administering spinal anaesthesia ) followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till complete sensory and motor recovery. 2. Heart rate will be recorded at baseline followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till recovery from sensory and motor blockade.	—

Measure

Time frame

Mean change in vital parameters (heart rate, blood pressure , respiratory rate, oxygen saturation) Frequency of adverse events Timepoint: 1.Blood pressure will be recorded at baseline ( immediately after administering spinal anaesthesia ) followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till complete sensory and motor recovery. 2. Heart rate will be recorded at baseline followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till recovery from sensory and motor blockade.

—

Countries

India

Contacts

Public ContactDr Deepali Shetty

Kasturba medical college

deepali.shetty@manipal.edu7349215023

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026