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.
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.
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.
- Conditions
- Lower Limb Injuries
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ropivacaine 0,5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted7 Nov 2024
- Study start1 Jan 2021
- Primary completion30 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ibrahim cardiac hospital and research institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
- Responsible party
- Principal investigator, Raju Ahmed, ibrahim cardiac hospital and research institute
- Investigators
- raju ahmed, Principal investigator, ibrahim cardiac resech
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 0.5% Bupivacaine and 0.5% Ropivacaine in Per Operative Continuous Lumber Epidural Anaesthesia of Lower Limb Bypass Surgery
- ClinicalTrials.gov ID
- NCT06677697
- Acronym / sponsor ID
- ICHRI/res/GA/2020/02
- Conditions
- Lower Limb Injuries
- Keywords
- Ropivacaine, Bupivacaine,, Epidural Anaesthesia,, Lower limb Bypass surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ibrahim cardiac hospital and research instituteUniversity, hospital or other
- Collaborators
- Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Ropivacaine 0,5%Group B 30 participant received 0.5% rupivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sixty patients who underwent lower limb surgery -
Key exclusion criteria (2 listed)
- non operative patients
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0,5%Group B 30 patients recive 0.5% ropivacine | Drug | Group B 30 participant received 0.5% rupivacaine |
Primary outcome
compare the efficacy of drug
Time frame: 6 months
compare the efficacy of 0.5% Bupivacaine with 0.5% Ropivacaine in lumber epidural block for lower limb bypass surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
raju ahmed principal investigator
ibrahim cardiac resech
1 site in 1 country: see every site and its status.
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.