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Underdosing of Local AnestheticsPhase 4NCT03838120

Determination of Minimum Effective Volume of Local Anesthetic in Patients Undergoing Ultrasound-Guided Infraclavicular Approach for Brachial Plexus Blockade

A Phase 4 study testing Procedure/Surgery: bupivakain % 0,5 in people with Underdosing of Local Anesthetics and Anesthetics, Local, run by Ankara City Hospital Bilkent.

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

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 70 years
What is being tested?
Procedure/Surgery: bupivakain % 0,5
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
1 Nov 2015to 1 Nov 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 18-70 years of age who were determined as ASA I-III and underwent upper limb surgery from November 2015 to November 2016 and provided informed consent, were included in the study.

Who cannot join

  • Patients who had any of the following conditions were excluded: ASA risk score of IV or V, serious cardiac, respiratory, hepatic or renal comorbidities, mental disorder, coagulopathy, pregnancy, local anesthetic allergy, neuromuscular and/or neurological disease, and infection at the site of injection. Patients who were unwilling to participate were also excluded

About this study

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 İnfraclavicular Approach for Brachial Plexus Blockade in upper limb operations.

Read the detailed description

This study was planned as a controlled, double-blind, single center study. Patients between 18-70 years of age who were determined as ASA I-III and underwent upper limb surgery from November 2015 to November 2016 and provided informed consent, were included in the study. Patients who had any of the following conditions were excluded: ASA risk score of IV or V, serious cardiac, respiratory, hepatic or renal comorbidities, mental disorder, coagulopathy, pregnancy, local anesthetic allergy, neuromuscular and/or neurological disease, and infection at the site of injection field of application. Patients who were unwilling to participate were also excluded. Randomization was done according to the time of patient referral with the sealed envelope system. Ethical approval was obtained from Ankara University Clinical Research Ethic Committee. All patients providedgave informed consent.

All procedures were performed by the same physician (S.B). In each patient, routine anesthesia monitoring was established and patients were administeredgiven 0.03 mg/kg midazolam and 1µg/kg of fentanyl for sedation. Field of applicationThe site of injection was properly prepared according to asepsis and antisepsis guidelines.

The infraclavicular blockade was performed according to the lateral sagittal infraclavicular block (LSIB) technique reported by Klaastad et al. [8]. The technique was modified to include ultrasound guidance, which was performed with a 6-12 mHz lineer ultrasound probe. The infraclavicular blockade was performed according to the lateral sagittal infraclavicular block (LSIB) technique reported by Klaastad et al. [8]. The technique was modified to include ultrasound guidance, which was performed with a 6-12 mHz lineer ultrasound probe. During the procedure, the patient was in the supine position with the head turned away from the application sidewith the head turned away from the application side and the shoulder was relaxed. The arm on the operative side undergoing surgery was slightly abducted, the elbow was flexed 90° and placed on the body of the patient. The anesthesiologist performing the procedure was positioned beside the head of the patient. The US probe was placed 1 cm inferior to the point of intersection between the clavicula and coracoid process on the sagittal axis. The in-plane technique was used during the procedure and the needle was visualized at all times. In order to obtain appropriate spread, the local anesthetic (0.5% [5 mg/ml] bupivacaine) was applied in a U shape from 3 to 11 o'clock around the axillary artery. U-shape distribution was achieved with (iğne pozisyonu yazılmalı); however, if distribution could not be achieved, the needle was repositioned when necessary.

The order of surgery was decided in a first come-first serve manner and Tthe volume of local anesthetic was reduced from a starting dose of 30 ml's in the first group. Five patients were included in each volume group and at least 3 applications out of 5 had to be successful to consider the volume to be sufficient. If the previous group's anesthesia was deemed as successful, the anesthesiologist reduced the dose by 2 ml's every 5 patients. When the anesthesia of a group of patients was determined to be unsuccessful (≤2 successful blockageblockades) the study was ended (Figure 1).

The researcher which determined whetherif the blockade was successful (N.A.E) was blinded to the study protocol. Sensorial and motor block measurements were used to determine blockade success. In the evaluation of sensorial blockade, touch and cold sensation tests were used to evaluate each region innervated by axillary, musculocutaneous, median, radial, and ulnar nerves. Touch sensation was evaluated with the cotton wool test and cold sensation was evaluated with ice packs. Evaluation was performed by comparing each region with the corresponding contralateral region. A score of 0 meant no blockade, 1 meant analgesia (touch sensation present, heat sensation absent), and 2 meant complete blockade of that specific region.

Motor blockade was graded on a 3-point scale; 0= no blockade, 1= partial motor blockade, 2= complete motor blockade. In this evaluation, muscles innervated by the axillary, musculocutaneous, median, radial, and ulnar nerves were each tested for motor response. The lack of movement was accepted to show complete blockade, slight movements were accepted to show partial motor blockade (initiation of motor blockade), and normal movements were considered as absence of motor blockade.

Evaluation was performed every 5 minutes during the first 60 minutes. The maximum total score for sensorial and motor blockade was 2016. During evaluation, the anesthesia and blockageblockade was accepted to be unsuccessful if this score dropped below 12. Furthermore, a sensorial blockade score of at least 97 from the possible 108 was accepted to be a requirement for successful blockade.

If unsuccessful blockade was determined during the first 60 minutes of the procedure, LMA anesthesia was applied to the patient (all applications were routine procedures and were performed with the only long-acting local anesthetic available in our hospital, 0.5% bupivacaine).

The initiation of motor and sensorial blockade was accepted as the time at which Bromage scale score changed from 0 to 1 and. tThe time of regression was accepted as the time at which score dropped below 1 for each region. The post-operative pain of patients was evaluated via the visual analogue scale (VAS) aton post-op 2, 4, 8, 12, 16, and 24 hours. Assessment of VAS was made with a 10 cm ruler with numbers from 0 to 10. The requirement for additional analgesic was accepted as the time at which VAS score increased above 4. Surgery duration, patient satisfaction and surgeon satisfaction were evaluated and measured as very good, good, moderate, and poor.

Being tested
Procedure/Surgery: bupivakain % 0,5
Keywords
Ultrasound, Minimum, Infraclavicular block

What participants receive

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

  • Procedure/Surgery: bupivakain % 0,5Other

    In this study, 5 patients were included in each volume group and at least 3 applications out of 5 had to be successful to consider the volume to be sufficient. After a successful group, the volume was reduced by 2 ml's and the same procedure was followed until a final group with unsuccessful anesthesia was found (≤2 successful blockades). The study was ended at this point and MEV was determined as the volume used in the last successful group. The researcher which determined the success of blockade was blinded to the study protocol. BMI, ASA Score, Successful blockade onset time Regression time of sensorial blockade Regression time of motor blockade Time of first additional analgesic requirement

Study groups in NCT03838120
Study groupRoleWhat they receive
Bupivacaine 0,5% Single arm studyOtherBupivacaine 0,5% Single arm study
Receives: Other: Procedure/Surgery: bupivakain % 0,5

What is being measured

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

  1. minimum effective volume

    Determining the minimum effective volume of bupivacaine 0,5% for successful ultrasound guided infraclavicular brachial plexus block for upper limb surgery

    Measured: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 60 minutes.

Secondary outcomes (4)
  1. Successful blockade onset time

    Sensorial and motor block measurements were used to determine blockade success.

    Measured: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 60 minutes.

  2. Regression time of sensorial blockade

    The initiation of motor and sensorial blockade was accepted as the time at which Bromage scale score changed from 0 to 1 and the time of regression was accepted as the time at which score dropped below 1 for each region

    Measured: post-op 2, 4, 8, 12, 16, and 24 hours.

  3. Regression time of motor blockade

    The initiation of motor and sensorial blockade was accepted as the time at which Bromage scale score changed from 0 to 1 and the time of regression was accepted as the time at which score dropped below 1 for each region

    Measured: post-op 2, 4, 8, 12, 16, and 24 hours.

  4. Time of first additional analgesic requirement

    The requirement for additional analgesic was accepted as the time at which VAS score increased above 4hours

    Measured: The post-operative pain of patients was evaluated via the visual analogue scale (VAS) at post-op 2, 4, 8, 12, 16, and 24 hours

Timeline

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

  1. First posted12 Feb 2019
  2. Study start1 Nov 2015
  3. Primary completion1 Apr 2016
  4. Study completion1 Nov 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
Prevention
Allocation
Not applicable
Intervention model
Sequential
Model description
A total of 48 ASA I-II patients underwent upper limb surgery operation by administering USG guided-infraclavicular blockage were included in the study. brachial plexus were seen and the minimum effective LA volume was investigated starting with total 30 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased 2ml. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838120
Sponsor's protocol ID
AnkaranTRH1
Status last verified
Feb 2019
First submitted
10 Feb 2019
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Procedure/Surgery: bupivakain % 0,5 in people with Underdosing of Local Anesthetics and Anesthetics, Local, 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 1 inclusion and 1 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 27 Oct 2021. 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 (time frame: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 60 minutes.). 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 27 Oct 2021.

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