Lower Limb SurgeryPhase 4NCT02201784

Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery

A Phase 4 study testing Levobupivacaine and Ropivacaine in people with Lower Limb Surgery, run by Aligarh Muslim University at 1 site in India.

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

The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Lower Limb Surgery
What is being tested?: Levobupivacaine and Ropivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteIndia
Study dates: Dec 2012to Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult

Who may be able to join

American Society of Anesthesiologists (ASA) class I \& II patients of either sex
Age between 18-60 years

Who cannot join

Patient's refusal.
Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
Patients having h/o diabetes, neurological and musculoskeletal diseases.

Trial locations and contacts

1 site in 1 country.

India1 site

Jawaharlal Nehru medical college, AMU
Aligarh, Uttar Pradesh, 202002

Other trials in India

About this study

Official title: A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.

The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia

Read the detailed description

Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.

Conditions: Lower Limb Surgery
Being tested: Levobupivacaine, Ropivacaine
Keywords: Subarachnoid block, intrathecal, spinal anesthesia, isobaric, levobupivacaine, ropivacaine

What participants receive

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

LevobupivacaineDrug
Also called Chirocaine
Comparison of Equipotent doses
RopivacaineDrug
Also called Naropin
Comparison of equipotent doses

Study groups in NCT02201784
Study group	Role	What they receive
Levobupivacaine 0.5%	Active comparator	intrathecal administration of 15 mg of Levobupivacaine 0.5% Receives: Drug: Levobupivacaine
Ropivacaine 0.75%	Active comparator	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Receives: Drug: Ropivacaine

What is being measured

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

Duration of Analgesia
Defined as time for first analgesic request by the patient
Measured: 8 hours

Secondary outcomes (5)

Onset of Sensory Block at T10
level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.
Measured: 30 minutes
Median Maximum Level of Sensory Blockade
level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.
Measured: 8 hours
Time to Maximum Cephalic Spread of Sensory Block
Measured: 8 hours
Onset of Motor Block to Bromage3
Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).
Measured: 8 hours
Duration of Motor Block
Time when the Bromage score will be back to zero
Measured: 8 hours

Timeline

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

Dec 2012Jan 2014

First posted28 Jul 2014 (estimated)
Study startDec 2012
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lower Limb SurgeryStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02201784
Sponsor's protocol ID: jnmch2012
Status last verified: Jan 2015
First submitted: 24 Jul 2014
Last updated: 21 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lower Limb Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.
ClinicalTrials.gov ID: NCT02201784
Acronym / sponsor ID: jnmch2012
Conditions: Lower Limb Surgery
Keywords: Subarachnoid block, intrathecal, spinal anesthesia, isobaric, levobupivacaine, ropivacaine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Aligarh Muslim UniversityUniversity, hospital or other
Study start: Dec 2012
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 28 Jul 2014 (estimated)
Results: Posted 21 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Levobupivacaine 0.5%	Active comparator	Drug: Levobupivacaineintrathecal administration of 15 mg of Levobupivacaine 0.5%
Ropivacaine 0.75%	Active comparator	Drug: Ropivacaineintrathecal administration of 22.5 mg of Ropivacaine 0.75%

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

American Society of Anesthesiologists (ASA) class I \& II patients of either sex
Age between 18-60 years

Key exclusion criteria (3 listed)

Patient's refusal.
Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
Patients having h/o diabetes, neurological and musculoskeletal diseases.

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
LevobupivacaineAlso: ChirocaineComparison of Equipotent doses	Drug	Levobupivacaine 0.5%
RopivacaineAlso: NaropinComparison of equipotent doses	Drug	Ropivacaine 0.75%

Primary outcome

Duration of Analgesia
Time frame: 8 hours
Defined as time for first analgesic request by the patient

5 secondary outcomes

Onset of Sensory Block at T10
Time frame: 30 minutes
Median Maximum Level of Sensory Blockade
Time frame: 8 hours
Time to Maximum Cephalic Spread of Sensory Block
Time frame: 8 hours
Onset of Motor Block to Bromage3
Time frame: 8 hours
Duration of Motor Block
Time frame: 8 hours

Results and safety

Results posted to the registry on 21 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levobupivacaine 0.5%	30	28
Ropivacaine 0.75%	30	30

Primary outcome: Duration of Analgesia

Time frame: 8 hours. Mean (Standard Deviation). Unit: minutes

Measure	Levobupivacaine 0.5% n = 28	Ropivacaine 0.75% n = 30
Value	309.83 (36.45)	249.50 (22.83)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levobupivacaine 0.5%	0 of 30 (0%)	11 of 30 (36.7%)	Not reported
Ropivacaine 0.75%	0 of 30 (0%)	13 of 30 (43.3%)	Not reported

Limitations and caveats (from the sponsor): Exact baricity was not known as Specific gravity was not measured; Quality of anaesthesia was not assessed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lower Limb Surgery

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
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Active, not recruiting
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Femoral Neck Fractures, Nerve Block
Recruiting
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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.

Manazir Athar, M.D principal investigator

Jawaharlal Nehru Medical College, AMU,Aligarh, India

Syed Moied Ahmed, PhD, M.D study director

Jawaharlal Nehru Medical College, AMU, Aligarh, India

Masood H Siddiqi, M.S study director

Jawaharlal Nehru Medical College, AMU, Aligarh, India

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 Levobupivacaine and Ropivacaine in people with Lower Limb Surgery, run by Aligarh Muslim University 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 2 inclusion and 3 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 21 Jan 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.

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?

Yes. Results are posted in the registry (first posted 21 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Duration of Analgesia (time frame: 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02201784.

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 21 Jan 2015.