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Lower Limb InjuriesPhase 4NCT06677697

Comparative Study of Bupivacaine and Ropivacaine in Lumber Epidural Lower Limb Bypass Surgery

A Phase 4 study testing Ropivacaine 0,5% in people with Lower Limb Injuries, run by ibrahim cardiac hospital and research institute at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lower Limb Injuries
What is being tested?
Ropivacaine 0,5%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBangladesh
Study dates
1 Jan 2021to 1 Nov 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sixty patients who underwent lower limb surgery -

Who cannot join

  • non operative patients
  • -

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • Ibrahim Cardiac Hospital and Research Institute

    Dhaka

Other trials in Bangladesh

About this study

Official title: Comparative Study of 0.5% Bupivacaine and 0.5% Ropivacaine in Per Operative Continuous Lumber Epidural Anaesthesia of Lower Limb Bypass Surgery

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.

Read the detailed description

Introduction:

Epidural anaesthesia has been found to be a well-known technique for lower limb bypass surgeries as it provides effective sensory and motor blockade in an awake patient for longer duration. Moreover, Epidural anaesthesia provides better control of pain and satisfactory analgesia in postoperative period without any respiratory complications. Bupivacaine \& Ropivacaine both are amide local anaesthetics. Bupivacaine being more cardiotoxic there has been paradigm shift to ropivacaine which is less cardiotoxic and widely used in epidural and spinal anaesthesia to obtain intraoperative and postoperative pain relief with lesser side effects. It has been seen that ropivacaine blocks the sensory fibres more effectively as compared to the motor fibre. In addition; ropivacaine has been shown to have vasoconstrictor properties.

Our goal in this prospective, single blind, randomized study was to compare the anaesthetic characteristics of 0.5% Ropivacaine with that of 0.5% Bupivacaine when administered epidurally for lower limb bypass surgery.

Materials \& Methods

This randomized single-blind study was conducted from 1st January '2021 to 31st December '2022 at the department of Anaesthesiology, Ibrahim Cardiac Hospital and Research Institute, Shahbagh, Dhaka, Bangladesh. After institutional ethical committee approval and informed written consent, a total number of 60 adult patients were randomly allocated into two groups (n=30) using a computerized random number table. Patients with ASA physical status II \& III, aged between 30 and 60 years, scheduled for lower limb bypass surgeries were enrolled in this study.

Exclusion criteria included local infection at the site of puncture, patients having any neurological deficit in the lower limb, severe hepatic, respiratory, hematological disorders and known allergy to study drugs.

Group B received 0.5% Bupivacaine, and group R received 0.5% Ropivacaine for Epidural Anaesthesia.

Preoperative assessment included detailed history, physical examination, systemic examination, airway assessment and routine investigations, such as hemoglobin, total blood cell count, differential white blood cell count, platelet count, blood glucose, blood urea and serum creatinine. ECG and X-ray were also performed. Preoperative baseline vital parameters were recorded. Intravenous line was secured with an 18G canula, and infusion was started. Premedication was given with inj. Ondansetron 4 mg iv, inj. Ranitidine 50 mg iv. After skin infiltration with 1% Lidocaine, the epidural space was identified with loss of resistance method at the L4 \& L5 interspace in the midline with a 16-gauge Tuohy needle. With the bevel of the needle directed cranially a catheter was inserted 3-5 cm through the needle, then a 2 ml of test dose of the study drug was given. The patient was then placed supine and a further 12 ml of the study drug was administered over a 3-5 min period. Continuous epidural anaesthesia was maintained by 3-5 ml/h through syringe pump. Sensory and motor block were assessed at 5, 10, 15, 20, 30 minutes after injection, then at 30 minutes interval. Motor block was assessed by Bromage scale, and sensory block was assessed by the blunt end of a 27-gauge needle based on a dermatome chart. Heart rate, blood pressure, SPO2 were recorded every 5 minutes interval per operatively but data were analysis at 5 min, 15 min, 25 min, 35 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min interval. The following side effects were observed: nausea, vomiting, respiratory depression, shivering, and episode of hypotension (20% decreases in MAP in relation to baseline values), bradycardia (HR <50 beats/min), and hypoxemia (SpO2 <90%). If systolic blood pressure is <20% from base line or MAP <60 mmHg, IV ephedrine 5 mg was given incrementally. If the HR is <50 beats/min, 0.6 mg atropine sulfate was administrated. Other parameters like duration of onset of sensory and motor block were assessed.

Being tested
Ropivacaine 0,5%
Keywords
Ropivacaine, Bupivacaine,, Epidural Anaesthesia,, Lower limb Bypass surgeries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine 0,5%Drug

    Group B 30 patients recive 0.5% ropivacine

Study groups in NCT06677697
Study groupRoleWhat they receive
Group A 30 participant received 0.5% BupivacaineNo interventionGroup A 30 participant received 0.5% Bupivacaine
Group B 30 participant received 0.5% rupivacaineExperimentalGroup B 30 participant received 0.5% rupivacaine
Receives: Drug: Ropivacaine 0,5%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start1 Jan 2021
  3. Primary completion30 Oct 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06677697
Sponsor's protocol ID
ICHRI/res/GA/2020/02
Other IDs
ICHRI/res/GA/2020/02
Status last verified
Nov 2024
First submitted
29 Oct 2024
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine 0,5% in people with Lower Limb Injuries, run by ibrahim cardiac hospital and research institute at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare the efficacy of drug (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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