Comparison of Efficacy of 0.5% Hyperbaric Bupivacaine and 0.75%Isobaric Ropivacaine for Spinal Anaeshesia

NCT07777055 | Completed Phase 4 DMC

• 1 other identifier: 327/075/076
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anaesthesia is a preferred technique used for lower abdominal and lower limb surgeries as it provides faster and profound sensory and motor blockade. Bupivacaine is the most commonly used local anaesthetic in spinal anaesthesia. Earlier studies have suggested that Ropivacaine causes shorter duration of motor blockade and provides early ambulation to the patient. The aim of this double- blinded, prospective, randomized controlled study was to compare the effect of 0.5% Hyperbaric Bupivacaine and 0.75% Isobaric Ropivacaine for spinal anaesthesia.

Conditions

Spinal Anesthesia

Keywords

Spinal anesthesia ,

Outcome Measures

Primary Outcomes (1)

• duration of motor block

  duration of motor block among either drug

  from the time of first motor block confirmation on examination to the complete regression of motor block (Modified Bromage scale 6 on examination). Data taken at 0,10,15 minutes and thereafter every 30 minutes till full recovery.

Secondary Outcomes (3)

• duration of sensory block

  from the time of first examination for any sensory block till two segment regression of sensory block. Sensory block was tested at 0,5,10,20 and every 10 minutes thereafter till 2 segment regression from the first established highest sensory level.

• Pulse rate

  From the time of first examination for any sensory block till the end of surgery.

• Blood Pressure

  From the time of first examination for any sensory block till the end of surgery.

Study Arms (2)

spinal anesthesia with bupivacaine

ACTIVE COMPARATOR

bupivacaine 0.5% heavy, 3ml

Procedure: spinal anesthesia

spinal anesthesia with ropivacaine

ACTIVE COMPARATOR

ropivacaine 0.75% isobaric, 3ml

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

Spinal anesthesia with bupivacaine 0.5% or ropivacaine 0.75%

spinal anesthesia with bupivacaine; spinal anesthesia with ropivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AGE: \>18 years\>65years
• All ASA I and II patients
• Undergoing elective orthopaedic surgeries
• No contraindications for spinal anesthesia

You may not qualify if:

• pregnancy,
• obesity,
• ASA III and IV,
• emergency surgeries.

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead

Study Sites (1)

Institute of Medicine

Kathmandu, Bagmati, Nepal

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomly generated numbers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: August 20, 2026
• Study Start: December 28, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2026-09-21 till 2030-09-21
• Access Criteria: Everyone

Locations

NE (1)