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).
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
- Conditions the study is for
- Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical Trial
- 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
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 group | Role | What they receive |
|---|---|---|
| BLOCK SİDE | 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. Receives: Other: INTERSCALEN BLOCK APPLICATION WITH USG | |
| UNBLOCK SİDE | 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. Receives: Other: INTERSCALEN BLOCK APPLICATION WITH USG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted26 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical TrialStudies 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
- Observational
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Egitim Ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erdinç Koca, Malatya Egitim Ve Arastirma Hastanesi
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical Triall
- ClinicalTrials.gov ID
- NCT05208632
- Acronym / sponsor ID
- 123456
- Keywords
- brachial plexus, interscalene block, infraclavicular block, Perfusion index, Pleth Variability Index, regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Malatya Egitim Ve Arastirma HastanesiOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Jan 2022 (actual)
- 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.
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.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLOCK SİDE | – | Other: INTERSCALEN BLOCK APPLICATION WITH USG40 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. |
| UNBLOCK SİDE | – | Other: INTERSCALEN BLOCK APPLICATION WITH USG40 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will undergo upper-term surgery
Key inclusion criteria (3 listed)
- ASA classification (American Society of Anesthesiologists) I-II score
- no contraindications for block
- patient's acceptance
Key exclusion criteria (6 listed)
- Pediatric patients
- pregnant patients
- patients with peripheral arterial disease
- renal failure
- liver 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 |
|---|---|---|
| INTERSCALEN BLOCK APPLICATION WITH USGAlso: SHOULDER SURGERY40 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. | Other | BLOCK SİDE, UNBLOCK SİDE |
Primary outcome
Perfusion index: PI
Time frame: 10 WEEK
monitoring, both upper extremities Perfusion index: PI, (The probe of a MasimoRadical 7, MasimoCorp. Irvine, CA, USA) were performed.
1 secondary outcome
Plethysmographic variability index: PVI
Time frame: 10 WEEK
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 26 Jan 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
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.