Pain Insensitivity, CongenitalNCT02513433
Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia
A study testing Bupivacaine, Levobupivacaine and Ropivacaine in people with Pain Insensitivity, Congenital, run by Government Medical College, Haldwani at 1 site in India.
Trial summary
This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Insensitivity, Congenital
- What is being tested?
- Bupivacaine, Levobupivacaine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Sep 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA Grade I and II patients of either sex
- Age 18-60 years
- Undergoing various hip surgeries under lumbar epidural anesthesia
Who cannot join
- Refusal for epidural
- ASA-III\&IV
- Head injury
- Psychiatric disease
- Known allergic to test drugs
- Major systemic disease
- Any analgesia with in past 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries
This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.
Read the detailed description
Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.
Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.
The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.
Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.
- Conditions
- Pain Insensitivity, Congenital
- Being tested
- Bupivacaine, Levobupivacaine, Ropivacaine
- Keywords
- Lumbar epidural anaesthesia
- Medical subject headings
- Pain Insensitivity, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Anawin, Sensorcaine
Local anesthetic
LevobupivacaineDrug
Also called Levo-anawin
Local anesthetic
RopivacaineDrug
Also called Ropin
Local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine & Levobupivacaine | Active comparator | Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery Receives: Drug: Bupivacaine; Drug: Levobupivacaine |
| Bupivacaine & Ropivacaine | Active comparator | Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery Receives: Drug: Bupivacaine; Drug: Ropivacaine |
| Ropivacaine & Levobupivacaine | Active comparator | Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery Receives: Drug: Levobupivacaine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of sensory block
Time to achieve sensory block up to tenth thoracic dermatome
Measured: 30 minutes
Secondary outcomes (2)
Time for 2 segment regression of sensory block
Time for regression of sensory block 2 segments lower than maximum blocked dermatome
Measured: 90 minutes
Time to achieve maximum motor block
Time to achieve motor block of modified Bromage score
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Insensitivity, CongenitalStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Haldwani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Subhro Mitra, Government Medical College, Haldwani
- Investigators
- Geeta Bhandari, M.D., Principal investigator, Professor and Head of the department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513433
- Sponsor's protocol ID
- 65/IEC/01/12-13
- Status last verified
- Jul 2015
- First submitted
- 30 Jul 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries
- ClinicalTrials.gov ID
- NCT02513433
- Acronym / sponsor ID
- 65/IEC/01/12-13
- Conditions
- Pain Insensitivity, Congenital
- Keywords
- Lumbar epidural anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Government Medical College, HaldwaniUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.
Detailed description
Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.
Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.
The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.
Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine & Levobupivacaine | Active comparator | Drug: Bupivacaine, Drug: LevobupivacaineBupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery |
| Bupivacaine & Ropivacaine | Active comparator | Drug: Bupivacaine, Drug: RopivacaineBupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery |
| Ropivacaine & Levobupivacaine | Active comparator | Drug: Levobupivacaine, Drug: RopivacaineRopivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA Grade I and II patients of either sex
- Age 18-60 years
- Undergoing various hip surgeries under lumbar epidural anesthesia
Key exclusion criteria (7 listed)
- Refusal for epidural
- ASA-III\&IV
- Head injury
- Psychiatric disease
- Known allergic to test drugs
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 |
|---|---|---|
| BupivacaineAlso: Anawin, SensorcaineLocal anesthetic | Drug | Bupivacaine & Levobupivacaine, Bupivacaine & Ropivacaine |
| LevobupivacaineAlso: Levo-anawinLocal anesthetic | Drug | Bupivacaine & Levobupivacaine, Ropivacaine & Levobupivacaine |
| RopivacaineAlso: RopinLocal anesthetic | Drug | Bupivacaine & Ropivacaine, Ropivacaine & Levobupivacaine |
Primary outcome
Onset of sensory block
Time frame: 30 minutes
Time to achieve sensory block up to tenth thoracic dermatome
2 secondary outcomes
Time for 2 segment regression of sensory block
Time frame: 90 minutes
Time to achieve maximum motor block
Time frame: 45 minutes
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 4 Aug 2015.
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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.
Geeta Bhandari, M.D. principal investigator
Professor and Head of the department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Levobupivacaine and Ropivacaine in people with Pain Insensitivity, Congenital, run by Government Medical College, Haldwani at 1 site in India.
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 3 inclusion and 7 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 4 Aug 2015. 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 India. 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.
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?
Onset of sensory block (time frame: 30 minutes). 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 4 Aug 2015.