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Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical TrialNCT05208632

Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical Triall

An observational study of Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical Trial, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).

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

Abstract: Background: In investigators study, we aimed to compare PI and PVI between the interscalen block and infraclavicular block and evaluate its use as an early marker in block success. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
INTERSCALEN BLOCK APPLICATION WITH USG
How many people
2 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 1 May 2021
Phase
Observational
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients who will undergo upper-term surgery

Who may be able to join

  • ASA classification (American Society of Anesthesiologists) I-II score
  • no contraindications for block
  • patient's acceptance

Who cannot join

  • Pediatric patients
  • pregnant patients
  • patients with peripheral arterial disease
  • renal failure
  • liver failure
  • coagulation disorder

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Malatya Eğitim Ve Araştirma Hastanesi

    Malatya, 44100

Other trials in Turkey (Türkiye)

About this study

Abstract:

Background: In investigators study, we aimed to compare PI and PVI between the interscalen block and infraclavicular block and evaluate its use as an early marker in block success.

Meterial- Methods: 40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.

Read the detailed description

investigators study, which was designed as a prospective clinical study, was initiated in accordance with the according to the consort flow diagram, after the approval of the clinical research ethics committee of Malatya Turgut Özal University, dated 03.08.2021 and numbered 2021/43. investigators study was carried out in accordance with the Helsinki declaration published in 2013.The patients were randomly divided into two groups as the patients who underwent interscalen block (ISB) and infraclavicular block (ICB) by the closed-envelope method by a blind nurse who did not participate in the study. Based on similar studies, the sample size of the study was calculated as 0.05 patients with alpha and 0.8 patients with a beta, 20 patients in each group, a total of 40 patients. 46 patients over the age of 18 with ASA classification (American Society of Anesthesiologists) I-II, who were planned to undergo upper extremity surgery, were included in the study. 6 patients were excluded from the study because they were switched to general anesthesia, and 40 patients who developed successful block were included in the study. Pediatric patients, pregnant patients, patients with peripheral arterial disease, heart failure with a hemoglobin level of 10, renal failure, liver failure, coagulation disorder with neuropathy, and patients with known allergy to local anesthetics were excluded from the study. Wet signed informed consent was obtained from all patients.

All patients included in the study were examined by an anesthesiologist before anesthesia. Following the appropriate fasting period, the patients were taken to the preparation room and routine monitoring (peripheral oxygen saturation, non-invasive arterial measurement of blood pressure and Electrocardiogram) were performed. Vascular access was established with a 20G branule in the other arm, which did not undergo surgery. The patients were administered midazolam (0.05-0.1 mg/kg, Dormicum 5mg/5cc, Deva İlaç, Istanbul) for sedation before the procedure. Nasal oxygen was given at 2-4 L/min. In addition to routine monitoring, both upper extremities Perfusion index: PI, Plethysmographic variability index: PVI, hemoglobin HGB, (The probe of a MasimoRadical 7, MasimoCorp. Irvine, CA, USA) were performed. Using an insulated neurostimulation needle (22 G, 50 mm Locoplex, Vygon®, France) accompanied by USG (Samsung HM70 Evo, South Korea) and nerve stimulator (Stimuplex, HNS 11; Braun Melsunçgen, Melsungen, Germany) Interscalen block was performed in 20 patients and the infraclavicular block were performed in 20 patients. After turning the head to the opposite side of the patients in the interscalen group, a skin anti setting was provided with povidone-iodine in the treatment area. The USG probe was placed transversely obliquely from the level of the cricoid cartilage (C6) to the line connecting the interscalen space and the brachial plexus was found and 22G 50 mm insulated nerve stimulator needle was inserted in-plain with a posterior approach and 10 mL of 0.5% bupivacaine, 10 mL of 2% lidocaine, 10 mL of 2% prilocaine were injected considering the loss of response at currents less than 0.2-0.3 mA to avoid the risk of intraneural injection after a distal motor response was found at <0.5 mA with a nerve stimulator. In the infraclavicular group, after the area was cleaned with povidone-iodine, the USG probe was placed in the area where the clavicle and the cricoid process intersect, and the anatomical structure was observed. A 22G 50 mm stimulator needle was inserted with the in-plain approach, and after the distal motor response was found at < 0.5 mA with the nerve stimulator, to avoid the risk of intraneural injection, considering the loss of response at currents less than 0.2-0.3 mA, 10 mL % 0.5 bupivacaine, 10 ml 2% lidocaine, 10 ml 2% prilocaine injections were administered. The development of sensorineural block (inability to identify the cold application) in the motor block and related dermatomes was accepted as a successful block.

Demographic data such as age, gender, height, weight, and body mass index (BMI) of the patients and entry hemoglobin levels were recorded. Heart rate per minute (HR) systolic blood pressure (SAP) diastolic blood pressure (DAP) peripheral oxygen saturation (SpO2) and simultaneous block and contralateral Perfusion index: PI, Plethysmographic index of variability: PVI values were recorded by measuring baseline, post-block 1st, 5th, 10th, 15th, and 20th values. After the measurements, the patients with successful block were presented to surgery. Patients without complications after surgery were transferred to the service.

Being tested
INTERSCALEN BLOCK APPLICATION WITH USG
Keywords
brachial plexus, interscalene block, infraclavicular block, Perfusion index, Pleth Variability Index, regional anesthesia

What participants receive

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

  • INTERSCALEN BLOCK APPLICATION WITH USGOther

    Also called SHOULDER SURGERY

    40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.

Study groups in NCT05208632
Study groupRoleWhat they receive
BLOCK SİDE40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.
Receives: Other: INTERSCALEN BLOCK APPLICATION WITH USG
UNBLOCK SİDE40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.
Receives: Other: INTERSCALEN BLOCK APPLICATION WITH USG

What is being measured

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

  1. Perfusion index: PI

    monitoring, both upper extremities Perfusion index: PI, (The probe of a MasimoRadical 7, MasimoCorp. Irvine, CA, USA) were performed.

    Measured: 10 WEEK

Secondary outcomes (1)
  1. Plethysmographic variability index: PVI

    monitoring, both upper extremities , Plethysmographic variability index: PVI, (The probe of a MasimoRadical 7, MasimoCorp. Irvine, CA, USA) were performed.

    Measured: 10 WEEK

Timeline

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

  1. First posted26 Jan 2022
  2. Study start1 Jan 2021
  3. Primary completion1 Mar 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05208632
Sponsor's protocol ID
123456
Status last verified
Jan 2022
First submitted
13 Dec 2021
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical Trial, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).

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 3 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 26 Jan 2022. 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 Turkey (Türkiye). 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 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?

Perfusion index: PI (time frame: 10 WEEK). 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 26 Jan 2022.

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