Other Surgical ProceduresPhase 4NCT01309360
Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine
A Phase 4 study testing midazolam and prilocaine 1% in people with Other Surgical Procedures, run by Helios Research Center.
Trial summary
Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus anesthesia have any effect on the success rate and additional parameters of block quality? Methodology: In this prospective cohort study three groups of 40 outpatients each were administered dosages of 1% prilocaine of either… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Other Surgical Procedures
- What is being tested?
- midazolam and prilocaine 1%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Apr 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective surgery on the distal forearm or the hand
- adult outpatients, age 18-75 years old
- ASA-risk groups I-II (American Society of Anesthesiologists)
- Body Mass Index 17-35
- informed consent
Who cannot join
- severe coagulopathy
- local or systemic inflammatory response
- ASA-risk groups ≥ Grad III
- severe anemia
- heart failure
- manifest shock
Show all 14Show fewer
- other drugs with influence on methaemoglobinemia (nitrates, sulfonamides etc.)
- domestic care after surgery not ensured
- drug allergy : local anesthetics
- severe polyneuropathy
- pregnancy, lactation period
- participation in other studies
- non-cooperative patients
- addiction to drugs or alcohol
About this study
Official title: Ultrasound-guided Block of the Brachial Plexus Using Prilocaine: Effects of Local-anesthetic Dose Reduction on Parameters of Block Quality and Adverse Effects in Outpatients
Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus anesthesia have any effect on the success rate and additional parameters of block quality? Methodology: In this prospective cohort study three groups of 40 outpatients each were administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus anesthesia. Met-Hb was measured prior to administration of the block and then hourly until the Met-Hb concentration fell. Parameters of block quality and any adverse effects were recorded. The level of significance was defined with α ≤ 0.05.
Read the detailed description
Background
With the availability of high resolution portable ultrasound equipment, the use of sonography in the field of anesthesia has become more widespread in recent years. The investigators would like to draw attention to a meta-analysis of prospective randomized studies by Abrahams et al. as being representative of the numerous publications available. Compared to nerve stimulation, ultrasound-guided nerve blocks have a higher success rate with significantly fewer vascular punctures and shorter procedure times. However, the administration of ultrasound-guided regional anesthesia necessitates considerable equipment acquisition and training expenses. Nevertheless, the suggested benefits resulting from savings in time and local anesthetic, increased patient satisfaction and avoidance of complications should be considered in addition to the results from Abrahams et al.
The aim of the present work was to investigate whether an ultrasound-guided block combined with a reduced dose of the local anesthetic prilocaine altered the success rate or other parameters of block quality. Any adverse effects and the methaemoglobin concentration were also recorded.
Methodology
After receiving ethics committee approval and after informing patients, ultrasound-guided axillary plexus anesthesia was carried out on 120 adult outpatients in ASA risk groups I-II. The surgical spectrum covered procedures on the distal forearm or the hand (carpal tunnel syndrome, ganglion extirpation, removal of material, etc.). Provision of information and inclusion in the study was done in the anesthesia outpatients' clinic as part of the standard preoperative preparation. Prior to administering the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). Application of the local anesthesia was done prospectively and single blind in 3 cohorts with decreasing dosage. The patients received either 400mg (group A), 300mg (group B) or 200mg (group C) of prilocaine 1%. The block was performed under sterile conditions using a portable ultrasound device (Sonosite S-Nerve) and a 24 G short bevel cannula with flexible tubing. The block was performed using combined out-of-plane (n. musculocutaneous) and in-plane techniques (n.radialis, n.medianus, n.ulnaris), usually from a single puncture site. The outpatients were cared for in the anesthesia care unit preoperatively and postoperatively until their discharge. NIBP, pulse oxymetry and ECG were continuously monitored. The discharge criteria were widespread regression of the block with a subjective feeling of well-being including adequate analgesia and stable vital signs with methemoglobin (Met-Hb) concentrations ≤ 5%. Met-Hb levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. A complete sensory block of all 4 nerves within 60 minutes of administration of the local anesthetic was rated as a successful block.
For the statistical analysis the investigators selected distribution-free, nonparametric test methods. The Mann-Whitney U test was used when comparing 2 groups and the Kruskal-Wallis test or Fisher's exact test was used when comparing more than 2 groups. The level of significance was defined with α ≤ 0.05. With multiple paired comparisons the significance level was adjusted using the Bonferroni correction. The Bravais-Pearson correlation coefficient rho describes the relationship between the maximum Met-Hb value and the weight-based prilocaine dose in mg/kg.
- Conditions
- Other Surgical Procedures
- Being tested
- midazolam, prilocaine 1%
- Keywords
- ultrasound, methaemoglobin, prilocaine, regional anesthesia, ASA risk groups I-II, adult outpatients, surgical spectrum covered procedures, distal forearm, hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Also called Dormicum
Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).
prilocaine 1%Drug
Also called Xylonest 1%
40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
prilocaine 1%Drug
Also called Xylonest 1%
40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
prilocaine 1%Drug
Also called Xylonest 1%
40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
| Study group | Role | What they receive |
|---|---|---|
| group A : 40ml Prilocaine 1% | Active comparator | 40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block Receives: Drug: midazolam; Drug: prilocaine 1% |
| group B : 30ml Prilocaine 1% | Active comparator | 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block Receives: Drug: midazolam; Drug: prilocaine 1% |
| group C : 20ml Prilocaine 1% | Active comparator | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block Receives: Drug: midazolam; Drug: prilocaine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Sensory Block
The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.
Measured: 60 minutes after administration of the local anesthetic
Number of Participants With Complete Motor Blocks
To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.
Measured: Within 60 minutes after administration of the local anesthetic
Onset Time.
Time from beginning of administration of the local anesthetic until complete sensoric block.
Measured: within 60 minutes after administration of the local anesthetic
Secondary outcomes (3)
Maximum Concentrations of Methemoglobin
Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic.
Measured: 0,1,2,3,4 hours post-dose
Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability
In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis.
Measured: Outpatients were followed for the duration of hospital stay, an average of six hours.
Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.
In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level.
Measured: Outpatients were followed for the duration of hospital stay, an average of six hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
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 Other Surgical ProceduresStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Ronald Seidel, Dr. med., Principal investigator, Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 SchwerinGeorg Rehmert, Dr.med., Study director, Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309360
- Sponsor's protocol ID
- A 2009 24
- Status last verified
- Jun 2011
- First submitted
- 4 Mar 2011
- Last updated
- 12 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Block of the Brachial Plexus Using Prilocaine: Effects of Local-anesthetic Dose Reduction on Parameters of Block Quality and Adverse Effects in Outpatients
- ClinicalTrials.gov ID
- NCT01309360
- Acronym / sponsor ID
- A 2009 24
- Conditions
- Other Surgical Procedures
- Keywords
- ultrasound, methaemoglobin, prilocaine, regional anesthesia, ASA risk groups I-II, adult outpatients, surgical spectrum covered procedures, distal forearm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Helios Research CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Posted 27 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus anesthesia have any effect on the success rate and additional parameters of block quality? Methodology: In this prospective cohort study three groups of 40 outpatients each were administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus anesthesia. Met-Hb was measured prior to administration of the block and then hourly until the Met-Hb concentration fell. Parameters of block quality and any adverse effects were recorded. The level of significance was defined with α ≤ 0.05.
Detailed description
Background
With the availability of high resolution portable ultrasound equipment, the use of sonography in the field of anesthesia has become more widespread in recent years. The investigators would like to draw attention to a meta-analysis of prospective randomized studies by Abrahams et al. as being representative of the numerous publications available. Compared to nerve stimulation, ultrasound-guided nerve blocks have a higher success rate with significantly fewer vascular punctures and shorter procedure times. However, the administration of ultrasound-guided regional anesthesia necessitates considerable equipment acquisition and training expenses. Nevertheless, the suggested benefits resulting from savings in time and local anesthetic, increased patient satisfaction and avoidance of complications should be considered in addition to the results from Abrahams et al.
The aim of the present work was to investigate whether an ultrasound-guided block combined with a reduced dose of the local anesthetic prilocaine altered the success rate or other parameters of block quality. Any adverse effects and the methaemoglobin concentration were also recorded.
Methodology
After receiving ethics committee approval and after informing patients, ultrasound-guided axillary plexus anesthesia was carried out on 120 adult outpatients in ASA risk groups I-II. The surgical spectrum covered procedures on the distal forearm or the hand (carpal tunnel syndrome, ganglion extirpation, removal of material, etc.). Provision of information and inclusion in the study was done in the anesthesia outpatients' clinic as part of the standard preoperative preparation. Prior to administering the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). Application of the local anesthesia was done prospectively and single blind in 3 cohorts with decreasing dosage. The patients received either 400mg (group A), 300mg (group B) or 200mg (group C) of prilocaine 1%. The block was performed under sterile conditions using a portable ultrasound device (Sonosite S-Nerve) and a 24 G short bevel cannula with flexible tubing. The block was performed using combined out-of-plane (n. musculocutaneous) and in-plane techniques (n.radialis, n.medianus, n.ulnaris), usually from a single puncture site. The outpatients were cared for in the anesthesia care unit preoperatively and postoperatively until their discharge. NIBP, pulse oxymetry and ECG were continuously monitored. The discharge criteria were widespread regression of the block with a subjective feeling of well-being including adequate analgesia and stable vital signs with methemoglobin (Met-Hb) concentrations ≤ 5%. Met-Hb levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. A complete sensory block of all 4 nerves within 60 minutes of administration of the local anesthetic was rated as a successful block.
For the statistical analysis the investigators selected distribution-free, nonparametric test methods. The Mann-Whitney U test was used when comparing 2 groups and the Kruskal-Wallis test or Fisher's exact test was used when comparing more than 2 groups. The level of significance was defined with α ≤ 0.05. With multiple paired comparisons the significance level was adjusted using the Bonferroni correction. The Bravais-Pearson correlation coefficient rho describes the relationship between the maximum Met-Hb value and the weight-based prilocaine dose in mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A : 40ml Prilocaine 1% | Active comparator | Drug: midazolam, Drug: prilocaine 1%40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block |
| group B : 30ml Prilocaine 1% | Active comparator | Drug: midazolam, Drug: prilocaine 1%40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block |
| group C : 20ml Prilocaine 1% | Active comparator | Drug: midazolam, Drug: prilocaine 1%40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- elective surgery on the distal forearm or the hand
- adult outpatients, age 18-75 years old
- ASA-risk groups I-II (American Society of Anesthesiologists)
- Body Mass Index 17-35
- informed consent
Key exclusion criteria (14 listed)
- severe coagulopathy
- local or systemic inflammatory response
- ASA-risk groups ≥ Grad III
- severe anemia
- heart failure
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 |
|---|---|---|
| midazolamAlso: DormicumPrior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). | Drug | group A : 40ml Prilocaine 1%, group B : 30ml Prilocaine 1%, group C : 20ml Prilocaine 1% |
| prilocaine 1%Also: Xylonest 1%40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block | Drug | group A : 40ml Prilocaine 1% |
| prilocaine 1%Also: Xylonest 1%40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block | Drug | group B : 30ml Prilocaine 1% |
| prilocaine 1%Also: Xylonest 1%40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block | Drug | group C : 20ml Prilocaine 1% |
Primary outcome
Number of Participants With Complete Sensory Block
Time frame: 60 minutes after administration of the local anesthetic
The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.
Number of Participants With Complete Motor Blocks
Time frame: Within 60 minutes after administration of the local anesthetic
To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.
Onset Time.
Time frame: within 60 minutes after administration of the local anesthetic
Time from beginning of administration of the local anesthetic until complete sensoric block.
3 secondary outcomes
Maximum Concentrations of Methemoglobin
Time frame: 0,1,2,3,4 hours post-dose
Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability
Time frame: Outpatients were followed for the duration of hospital stay, an average of six hours.
Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.
Time frame: Outpatients were followed for the duration of hospital stay, an average of six hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Other Surgical Procedures
Active, not recruitingPhase 2
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, NSCLC
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Not yet recruitingPhase 2
A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
Early-Stage Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
Carcinoma, Hepatocellular, Hepatocellular Cancer
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.
Ronald Seidel, Dr. med. principal investigator
Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
Georg Rehmert, Dr.med. study director
Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing midazolam and prilocaine 1% in people with Other Surgical Procedures, run by Helios Research Center.
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 5 inclusion and 14 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 12 Jul 2011. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2011). 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?
Number of Participants With Complete Sensory Block (time frame: 60 minutes after administration of the local anesthetic). The study lists 3 primary outcomes in all. 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 12 Jul 2011.