Renal Insufficiency, ChronicNCT01533545
Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
A study testing Mepivacaine with epinephrine and Plain mepivacaine in people with Renal Insufficiency, Chronic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Mepivacaine with epinephrine and Plain mepivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient acceptance of regional anaesthesia
Who cannot join
- peripheral arteriosclerosis
- diabetes mellitus
- bleeding disorder
- infection at the puncture site
- allergy to mepivacaine
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency
The aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Mepivacaine with epinephrine, Plain mepivacaine
- Keywords
- Mepivacaine, Epinephrine, Brachial plexus block, Renal insufficiency
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepivacaine with epinephrineDrug
Also called Carbocain-Adrenalin
Ultrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 μg (5 μg/mL)
Plain mepivacaineDrug
Also called Carbocain
Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Plain mepivacaine | Active comparator | Not described Receives: Drug: Plain mepivacaine |
| Mepivacaine with epinephrine | Active comparator | Not described Receives: Drug: Mepivacaine with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of mepivacaine
Measured: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade
Secondary outcomes (4)
Central circulation
Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance
Measured: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Peripheral tissue oxygenation
Near infrared spectrometry obtained from the triceps muscle of the blocked arm
Measured: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Cardiotoxicity of local anesthetic
12-lead ECG
Measured: 0, 5, 10, 20, 30, 45, and 60 min after blockade
Neurotoxicity of local anesthetic
Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity
Measured: Continuously for 1 hour after blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robertas Martusevicius, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Robertas Martusevicius, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533545
- Sponsor's protocol ID
- H-3-2011-154
- Other IDs
- 2012-000948-98
- Status last verified
- Apr 2014
- First submitted
- 8 Feb 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McEllistrem RF, Schell J, O'Malley K, O'Toole D, Cunningham AJ. Interscalene brachial plexus blockade with lidocaine in chronic renal failure--a pharmacokinetic study. Can J Anaesth. 1989 Jan;36(1):59-63. doi: 10.1007/BF03010889.
PubMed 2914337Norio K, Makisalo H, Isoniemi H, Groop PH, Pere P, Lindgren L. Are diabetic patients in danger at renal transplantation? An invasive perioperative study. Eur J Anaesthesiol. 2000 Dec;17(12):729-36. doi: 10.1046/j.1365-2346.2000.00760.x.
PubMed 11122310Niemi G. Advantages and disadvantages of adrenaline in regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):229-45. doi: 10.1016/j.bpa.2004.12.004.
PubMed 15966495Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
PubMed 15635516
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT01533545
- Acronym / sponsor ID
- H-3-2011-154
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Mepivacaine, Epinephrine, Brachial plexus block, Renal insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 15 Feb 2012 (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.
The aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain mepivacaine | Active comparator | Drug: Plain mepivacaine |
| Mepivacaine with epinephrine | Active comparator | Drug: Mepivacaine with epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient acceptance of regional anaesthesia
Key exclusion criteria (6 listed)
- peripheral arteriosclerosis
- diabetes mellitus
- bleeding disorder
- infection at the puncture site
- allergy to mepivacaine
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 |
|---|---|---|
| Mepivacaine with epinephrineAlso: Carbocain-AdrenalinUltrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 μg (5 μg/mL) | Drug | Mepivacaine with epinephrine |
| Plain mepivacaineAlso: CarbocainUltrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL) | Drug | Plain mepivacaine |
Primary outcome
Plasma concentration of mepivacaine
Time frame: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade
4 secondary outcomes
Central circulation
Time frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Peripheral tissue oxygenation
Time frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Cardiotoxicity of local anesthetic
Time frame: 0, 5, 10, 20, 30, 45, and 60 min after blockade
Neurotoxicity of local anesthetic
Time frame: Continuously for 1 hour after blockade
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Background: PubMed 2914337McEllistrem RF, Schell J, O'Malley K, O'Toole D, Cunningham AJ. Interscalene brachial plexus blockade with lidocaine in chronic renal failure--a pharmacokinetic study. Can J Anaesth. 1989 Jan;36(1):59-63. doi: 10.1007/BF03010889.
- Background: PubMed 11122310Norio K, Makisalo H, Isoniemi H, Groop PH, Pere P, Lindgren L. Are diabetic patients in danger at renal transplantation? An invasive perioperative study. Eur J Anaesthesiol. 2000 Dec;17(12):729-36. doi: 10.1046/j.1365-2346.2000.00760.x.
- Background: PubMed 15966495Niemi G. Advantages and disadvantages of adrenaline in regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):229-45. doi: 10.1016/j.bpa.2004.12.004.
- Background: PubMed 15635516Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
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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.
Robertas Martusevicius, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepivacaine with epinephrine and Plain mepivacaine in people with Renal Insufficiency, Chronic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 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: stopped early, as of the sponsor's last update on 16 Apr 2014. 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 Denmark. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Plasma concentration of mepivacaine (time frame: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade). 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 NCT01533545, which also lists 4 linked publications.
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 16 Apr 2014.