Underdosing of Local AnestheticsPhase 4NCT02837718
Minimum Effective Volume Of Local Anesthetic İn USG Guided Axillary Approach Brachial Plexus Block
A Phase 4 study testing bupivakain % 0,5 in people with Underdosing of Local Anesthetics, run by Ankara City Hospital Bilkent.
Trial summary
Background Peripheral nerve blocks with use of USG allowed visualisation of the structures and nerves and made the block administrations safe, quick and comfortable. However there are few publications concerning the minimum local anesthetic volume capable of providing blocks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Underdosing of Local Anesthetics
- What is being tested?
- bupivakain % 0,5
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were age over 18 and under 65 years
- informed consent (IC) signed by the patient
- indication for brachial plexus block (anesthesia and analgesia) in candidates forelective hand surgery
- ASA physical status I or II according to the American Society of Anesthesiologists
- body mass index (BMI) <35 kg/m2.
Who cannot join
- Cognitive impairment or active psychiatriccondition
- İnfection at the blockade puncture site
- Bleeding disorders
- History of local anesthetic allergy
- Pregnancy
- The patients does not want this method .
About this study
Background Peripheral nerve blocks with use of USG allowed visualisation of the structures and nerves and made the block administrations safe, quick and comfortable. However there are few publications concerning the minimum local anesthetic volume capable of providing blocks. In this study the investigastors aimed to find Minimum Effective Volume Of Local Anesthetic For Ultrasound-Guided Axillary Brachial Plexus Block in hand, elbow and forehand operations.
Materials \& Methods A total of 55 ASA I-II patients underwent hand surgery operation by administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.
Read the detailed description
Matherials and Method This randomized, prospective, double-blinded, single-center study was conducted in accordance with the most recent version of the Helsinki Declaration. Approval for the study was granted by the Ankara Numune Research and Training Hospital Ethics Committee. A total of 55 adult patients classified as American Society of Anesthesiologists (ASA) physical status I-II, who were to undergo elective, forearm, wrist or hand surgery were recruited in this trial. Written informed consent was obtained from each patient. Exclusion criteria were patients with coagulopathy, local anesthetic allergy, local infection, any significant neurological, pysychiatric or congnitive disorder, chronic analgesic use, known neuropathies, infection in the injection site or unwillingness of the patient. After arrival in the operating room, an 20-gauge intravenous catheter was placed in the contralateral forearm. Standard monitoring was used throughout the procedure, including non-invasive arterial blood pressure, heart rate, and pulse oximetry. Patients were divided into groups according to their order of arrival and a five-person group was created. İnitial volume of 7 ml. Per nerve(ulnar, median, radial), totaly 21 ml local anesthetic administered in first group(first five patient). İf the success rate of block is three or more in the group, volume was reduced in the next group of 0.5 ml for each nerve. if the success rate is less than three in the group, study is ended. And minimum effective volume was calculated to be statistically.
Block prosedures All the brachial plexus blocks were performed by the same anesthesiologist. The patient is made comfortable in supine position with the arm abducted and the elbow flexed to 90 degrees. After skin and probe preparation, A linear US probe (HFL 38, 6-13MHz) was placed in the transverse plane at the lateral border of pectoralis major muscle to obtain the best view of the brachial plexus. Image quality is optimised with selection of appropriate depth (within 2 cm), focus range (within 1cm) and gain. The structures of interest are very superficial with the pulsating axillary artery localised within 1 cm . Surrounding the axillary artery, one will find the three out of four terminal branches of the brachial plexus: the median (superficial and lateral to the artery), the ulnar (superficial and medial to the artery) and the radial (posterior and lateral or medial to the artery) nerves. A 5 cm needle (21G, Locoplex, Vygon, Ecouen, France) is inserted parallel to the long axis of the transducer from the lateral side. As the needle is in the same plane as an ultrasound beam, the path of the advancement can be visualised in real time as the needle approaches the target nerves. Ideally, the radial nerve should be targeted first, as it lies posterior to artery, in order to prevent displacing the structures of interest to deeper and obscuring the median and ulnar nerves. The musculocutaneous nerve was blocked separately outside the neurovascular bundle with 3 ml %0.5 bupivacaine at all of the patient. We were also worried about the nerve puncture or intraneural injection. In addition, we also confirmed that the location of the needle tip was not in hypoechoic area before each injection. For further safety, we injected 0.5 ml of local anesthetic as a test dose. If the patients complained of paresthesia or pain, or the injection pressure was high, or the spread of local anesthetic was not visualized, investigastors stopped injection, and withdrew the needles and tried again. The investigastors regarded the paresthesia or pain, or high injection pressure as intraneural injection.
The investigator who testing the block is don't know the dose. Sensory block was evaluated for each nerve distribution using ice to test cold sensation, comparing the anaesthetized arm with the contralateral arm, and graded on a three-point scale (0, no difference between sides; 1, some difference between arms but cold still sensed in the blocked arm; 2, no cold sensation in the blocked arm). Motor block for each nerve was evaluated by asking the patient to extend the flexed arm and wrist (radial nerve), flex the wrist and oppose the second and third fingers and thumb (median nerve), flex and oppose fifth finger towards the thumb (ulnar nerve) and was graded as 0, no change; 1, reduced contraction; 2, no contraction. Data were collected every 5 min for the first 60 min, and then 1,2,4,6,8,10,12,18,24 hours. motor and sensory scale, the total value should be higher than 10, if not surgical anesthesia was considered unsuccessful. sensitive block score must be at least five. VAS determination was performed with a scale of numbers between 0 and 10 cm. 1mg/kg tramadol and 15 mg/kg paracetamol IV infusion were administered to patients with a reequirement for additional analgesia (VAS ≥ 4) . The total number of patients who required additional analgesic drugs was noted. During the initial procedures, the operation and postoperatively, patient satisfaction was evaluated as poor (1), moderate (2), good (3) or very good (4).
Statical Analysis Statistical analysis was applied using SPSS 19.0 statistical software.our sample size calculation method is dixon and massey up and down method. According to this account, n = 2 (SD / SEM) ²; n: sample size, SD (standard deviation): The standard deviation, SEM (standard error of mean) is calculated as the standard error of the mean (SD = 5 mL, SEM = 1.0 mL) n were found in 50 patients. For the aplicational errors we add 5 patient (%10 ). A total of 55 patients were included in the study.
The sample size calculation, made by G * Power 3.0.10 statistical software package (effect size (effect size) = 0.4, α = 0.05, degrees of freedom (df) = 48 and 0.85 power (power (1- β)), the number of 50 patients were found to be adequate. However for practical magnification error with a sample of 10% of 55 patients were included in the study.
- Conditions
- Underdosing of Local Anesthetics
- Being tested
- bupivakain % 0,5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivakain % 0,5Procedure or surgery
Bupivacaine 0,5% The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0,5% Single arm study | Other | Bupivacaine 0,5% Single arm study Receives: Procedure: bupivakain % 0,5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum effective volume of bupivacain %0.5
Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves
Measured: 1 hour
Secondary outcomes (1)
first analgesic requirement
Time of Visual analogue scale (VAS) over than 4. Measurument starts after operation finish.
Measured: 1 day (0,1, 2, 4, 6, 8, 10, 12, 18, 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underdosing of Local AnestheticsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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 4
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Model description
- A total of 55 ASA I-II patients underwent hand surgery operation by administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar, median and radial nerves were seen and the minimum effective LA volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, necati alper erdoğmuş, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837718
- Sponsor's protocol ID
- AnkaranTRH
- Status last verified
- Dec 2018
- First submitted
- 17 Jan 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Volume Of Local Anesthetic İn USG Guided Axillary Approach Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02837718
- Acronym / sponsor ID
- AnkaranTRH
- Conditions
- Underdosing of Local Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Jul 2016 (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.
Background Peripheral nerve blocks with use of USG allowed visualisation of the structures and nerves and made the block administrations safe, quick and comfortable. However there are few publications concerning the minimum local anesthetic volume capable of providing blocks. In this study the investigastors aimed to find Minimum Effective Volume Of Local Anesthetic For Ultrasound-Guided Axillary Brachial Plexus Block in hand, elbow and forehand operations.
Materials \& Methods A total of 55 ASA I-II patients underwent hand surgery operation by administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.
Detailed description
Matherials and Method This randomized, prospective, double-blinded, single-center study was conducted in accordance with the most recent version of the Helsinki Declaration. Approval for the study was granted by the Ankara Numune Research and Training Hospital Ethics Committee. A total of 55 adult patients classified as American Society of Anesthesiologists (ASA) physical status I-II, who were to undergo elective, forearm, wrist or hand surgery were recruited in this trial. Written informed consent was obtained from each patient. Exclusion criteria were patients with coagulopathy, local anesthetic allergy, local infection, any significant neurological, pysychiatric or congnitive disorder, chronic analgesic use, known neuropathies, infection in the injection site or unwillingness of the patient. After arrival in the operating room, an 20-gauge intravenous catheter was placed in the contralateral forearm. Standard monitoring was used throughout the procedure, including non-invasive arterial blood pressure, heart rate, and pulse oximetry. Patients were divided into groups according to their order of arrival and a five-person group was created. İnitial volume of 7 ml. Per nerve(ulnar, median, radial), totaly 21 ml local anesthetic administered in first group(first five patient). İf the success rate of block is three or more in the group, volume was reduced in the next group of 0.5 ml for each nerve. if the success rate is less than three in the group, study is ended. And minimum effective volume was calculated to be statistically.
Block prosedures All the brachial plexus blocks were performed by the same anesthesiologist. The patient is made comfortable in supine position with the arm abducted and the elbow flexed to 90 degrees. After skin and probe preparation, A linear US probe (HFL 38, 6-13MHz) was placed in the transverse plane at the lateral border of pectoralis major muscle to obtain the best view of the brachial plexus. Image quality is optimised with selection of appropriate depth (within 2 cm), focus range (within 1cm) and gain. The structures of interest are very superficial with the pulsating axillary artery localised within 1 cm . Surrounding the axillary artery, one will find the three out of four terminal branches of the brachial plexus: the median (superficial and lateral to the artery), the ulnar (superficial and medial to the artery) and the radial (posterior and lateral or medial to the artery) nerves. A 5 cm needle (21G, Locoplex, Vygon, Ecouen, France) is inserted parallel to the long axis of the transducer from the lateral side. As the needle is in the same plane as an ultrasound beam, the path of the advancement can be visualised in real time as the needle approaches the target nerves. Ideally, the radial nerve should be targeted first, as it lies posterior to artery, in order to prevent displacing the structures of interest to deeper and obscuring the median and ulnar nerves. The musculocutaneous nerve was blocked separately outside the neurovascular bundle with 3 ml %0.5 bupivacaine at all of the patient. We were also worried about the nerve puncture or intraneural injection. In addition, we also confirmed that the location of the needle tip was not in hypoechoic area before each injection. For further safety, we injected 0.5 ml of local anesthetic as a test dose. If the patients complained of paresthesia or pain, or the injection pressure was high, or the spread of local anesthetic was not visualized, investigastors stopped injection, and withdrew the needles and tried again. The investigastors regarded the paresthesia or pain, or high injection pressure as intraneural injection.
The investigator who testing the block is don't know the dose. Sensory block was evaluated for each nerve distribution using ice to test cold sensation, comparing the anaesthetized arm with the contralateral arm, and graded on a three-point scale (0, no difference between sides; 1, some difference between arms but cold still sensed in the blocked arm; 2, no cold sensation in the blocked arm). Motor block for each nerve was evaluated by asking the patient to extend the flexed arm and wrist (radial nerve), flex the wrist and oppose the second and third fingers and thumb (median nerve), flex and oppose fifth finger towards the thumb (ulnar nerve) and was graded as 0, no change; 1, reduced contraction; 2, no contraction. Data were collected every 5 min for the first 60 min, and then 1,2,4,6,8,10,12,18,24 hours. motor and sensory scale, the total value should be higher than 10, if not surgical anesthesia was considered unsuccessful. sensitive block score must be at least five. VAS determination was performed with a scale of numbers between 0 and 10 cm. 1mg/kg tramadol and 15 mg/kg paracetamol IV infusion were administered to patients with a reequirement for additional analgesia (VAS ≥ 4) . The total number of patients who required additional analgesic drugs was noted. During the initial procedures, the operation and postoperatively, patient satisfaction was evaluated as poor (1), moderate (2), good (3) or very good (4).
Statical Analysis Statistical analysis was applied using SPSS 19.0 statistical software.our sample size calculation method is dixon and massey up and down method. According to this account, n = 2 (SD / SEM) ²; n: sample size, SD (standard deviation): The standard deviation, SEM (standard error of mean) is calculated as the standard error of the mean (SD = 5 mL, SEM = 1.0 mL) n were found in 50 patients. For the aplicational errors we add 5 patient (%10 ). A total of 55 patients were included in the study.
The sample size calculation, made by G * Power 3.0.10 statistical software package (effect size (effect size) = 0.4, α = 0.05, degrees of freedom (df) = 48 and 0.85 power (power (1- β)), the number of 50 patients were found to be adequate. However for practical magnification error with a sample of 10% of 55 patients were included in the study.
Study design
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A total of 55 ASA I-II patients underwent hand surgery operation by administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar, median and radial nerves were seen and the minimum effective LA volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0,5% Single arm study | Other | Procedure: bupivakain % 0,5Bupivacaine 0,5% Single arm study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- were age over 18 and under 65 years
- informed consent (IC) signed by the patient
- indication for brachial plexus block (anesthesia and analgesia) in candidates forelective hand surgery
- ASA physical status I or II according to the American Society of Anesthesiologists
- body mass index (BMI) <35 kg/m2.
Key exclusion criteria (6 listed)
- Cognitive impairment or active psychiatriccondition
- İnfection at the blockade puncture site
- Bleeding disorders
- History of local anesthetic allergy
- Pregnancy
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 |
|---|---|---|
| bupivakain % 0,5Bupivacaine 0,5% The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min. | Procedure or surgery | Bupivacaine 0,5% Single arm study |
Primary outcome
Minimum effective volume of bupivacain %0.5
Time frame: 1 hour
Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves
1 secondary outcome
first analgesic requirement
Time frame: 1 day (0,1, 2, 4, 6, 8, 10, 12, 18, 24 hours)
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 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupivakain % 0,5 in people with Underdosing of Local Anesthetics, run by Ankara City Hospital Bilkent.
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 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: finished, as of the sponsor's last update on 13 Jan 2020. 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?
Minimum effective volume of bupivacain %0.5 (time frame: 1 hour). 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 13 Jan 2020.