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Other Peripheral Nerve DiseasePhase 4NCT02691442

Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery

A Phase 4 study testing Ropivacaine 0.75%, Levobupivacaine 0.5% and Levobupivacaine 0.5% + epinephrin 1/200000 in people with Other Peripheral Nerve Disease, run by University Hospital, Antwerp.

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

Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Other Peripheral Nerve Disease
What is being tested?
Ropivacaine 0.75%, Levobupivacaine 0.5% and Levobupivacaine 0.5% + epinephrin 1/200000
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Dec 2010to Apr 2016
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesia class I or II
  • Scheduled for shoulder surgery

Who cannot join

  • Mental retardation
  • Allergy for local anesthetics
  • NSAID intolerance or contraindicated
  • Diabetes mellitus
  • Chronic use of pain killers

About this study

Official title: Comparison of the Analgesic Effect of the Local Anesthetics Ropicacaine, Levobupivacaine, and Levobupivacaine + Epinephrin Via Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopy Under General Anesthesia

Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. The investigators want to use the novel method of Quantitative Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold sensation to assess small nerve fiber function. The investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.

Read the detailed description

This study aims to compare the length of the analgesic effect of different local anesthesic solutions, used in an interscalene nerve block. This will be objectified by measuring the changes in small nerve functioning, using quantative sensory testing. Based on the results of a previous study, the investigators reduce the dose of the administered local anesthetic, expecting a similar length of action using these smaller doses.

Being tested
Ropivacaine 0.75%, Levobupivacaine 0.5%, Levobupivacaine 0.5% + epinephrin 1/200000
Keywords
Peripheral nerve block

What participants receive

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

  • Ropivacaine 0.75%Drug

    Also called Naropin

    The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block

  • Levobupivacaine 0.5%Drug

    Also called Chirocaine

    The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block

  • Levobupivacaine 0.5% + epinephrin 1/200000Drug

    Also called Chirocaine

    The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block

Study groups in NCT02691442
Study groupRoleWhat they receive
Ropivacaine 0.75%Active comparatorThe investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space
Receives: Drug: Ropivacaine 0.75%
Levobupivacaine 0.5%Active comparatorThe investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space
Receives: Drug: Levobupivacaine 0.5%
Levobupivacaine 0.5% + epinephrinActive comparatorThe investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space
Receives: Drug: Levobupivacaine 0.5% + epinephrin 1/200000

What is being measured

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

  1. Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing

    Length of difference in cold and heat pain and sensation measured with quantitative sensory testing

    Measured: 24 hours after intervention

Secondary outcomes (3)

  1. Need for rescue drugs, as requested by the patient after surgery

    Measured: 24 hours after intervention

  2. Motor activity block, longitudinally recorded inability to move the blocked limb

    Measured: 24 hours after intervention

  3. Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing

    The difference in threshold of cold and heat pain and sensation measured with quantitative sensory testing

    Measured: 24 hours after intervention

Timeline

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

  1. First posted25 Feb 2016 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2015
  4. Study completionApr 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691442
Sponsor's protocol ID
EC 10/45/315
Status last verified
Aug 2016
First submitted
1 Feb 2016
Last updated
15 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sermeus LA, Schepens T, Hans GH, Morrison SG, Wouters K, Breebaart MB, Smitz CJ, Vercauteren MP. A low dose of three local anesthetic solutions for interscalene blockade tested by thermal quantitative sensory testing: a randomized controlled trial. J Clin Monit Comput. 2019 Apr;33(2):307-316. doi: 10.1007/s10877-018-0150-3. Epub 2018 May 3.

    PubMed 29725795

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine 0.75%, Levobupivacaine 0.5% and Levobupivacaine 0.5% + epinephrin 1/200000 in people with Other Peripheral Nerve Disease, run by University Hospital, Antwerp.

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 5 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing (time frame: 24 hours after intervention). 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 NCT02691442, which also lists 1 linked publication.

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 15 Aug 2016.

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