NCT06677697

Brief Summary

Regional anaesthesia is an important part in clinical anaesthesiology now a day. Epidural block is a commonly used regional technique alternative for general anaesthesia in case of lower limb bypass surgery. Bupivacaine and Ropivacaine both are amide local anaesthetics. This study was to compare the efficacy of 0.5% Bupivacaine with 0.5% Ropivacaine in lumber epidural block for lower limb bypass surgery. The aim of the study was to compare the hemodynamic changes and adverse effects between the two groups and the onset of sensory and motor blockade in lower limb bypass surgery. Material and method: Sixty(60) patients with American Society of Anaesthesiologists class II/III scheduled for elective lower limb bypass surgeries were randomly allocated into two groups .Group B received 0.5% Bupivacaine, and group R received 0.5% Ropivacaine for epidural anaesthesia at the level of L4 \& L5. The onset of sensory and motor block and adverse events during the peroperative period were noted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

October 29, 2024

Last Update Submit

November 5, 2024

Conditions

Lower Limb Injuries

Keywords

Ropivacaine, Bupivacaine,Epidural Anaesthesia,Lower limb Bypass surgeries

Outcome Measures

Primary Outcomes (1)

  • compare the efficacy of drug

    compare the efficacy of 0.5% Bupivacaine with 0.5% Ropivacaine in lumber epidural block for lower limb bypass surgery.

    6 months

Study Arms (2)

Group A 30 participant received 0.5% Bupivacaine

NO INTERVENTION

Group A 30 participant received 0.5% Bupivacaine

Group B 30 participant received 0.5% rupivacaine

EXPERIMENTAL

Group B 30 participant received 0.5% rupivacaine

Drug: Ropivacaine 0,5%

Interventions

Ropivacaine 0,5%DRUG

Group B 30 patients recive 0.5% ropivacine

Group B 30 participant received 0.5% rupivacaine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sixty patients who underwent lower limb surgery -

You may not qualify if:

  • non operative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibrahim Cardiac Hospital and Research Institute

Dhaka, Bangladesh

Location

Study Officials

  • raju ahmed

    ibrahim cardiac resech

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 7, 2024

Study Start

January 1, 2021

Primary Completion

October 30, 2022

Study Completion

November 1, 2022

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)