Carpal Tunnel SyndromeNCT04921891
Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block
A study testing Infraclavicular nerve block and Without nerve block in people with Carpal Tunnel Syndrome and Perfusion Index, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Perfusion Index
- What is being tested?
- Infraclavicular nerve block and Without nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2014to 30 Oct 2014
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18-75
- Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
- ASA I-II-III patients
Who cannot join
- Patients who will refuse this method
- Neurological deficits,
- Diabetes mellitus,
- Local anesthetic allergy,
- Morbidly obese,
- Peripheral vascular disease, coronary artery disease, or coagulopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Comparison of Block Success in Patients Undergoing Ultrasound-guided Infraclavicular Brachial Plexus Block With Bilateral Upper Extremity Perfusion Index
The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.
Read the detailed description
Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.
- Conditions
- Carpal Tunnel Syndrome, Perfusion Index
- Being tested
- Infraclavicular nerve block, Without nerve block
- Keywords
- Infraclavicular block, Perfusion index, Ultrasonography, Block assessment
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular nerve blockProcedure or surgery
The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.
Without nerve blockProcedure or surgery
The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.
| Study group | Role | What they receive |
|---|---|---|
| Blocked arm | Active comparator | The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia. Receives: Procedure: Infraclavicular nerve block |
| Unblocked arm | Active comparator | The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities. Receives: Procedure: Without nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of whether perfusion index is a reliable and objective method to indicate block success
Perfusion index was measured up to 6 hours after the procedure.
Measured: 6 hours postprocedurly
Secondary outcomes (1)
Determining of a cut-off value for PI and PI ratio for a successful block.
There may be changes in the cut-off value depending on the applied plexus area, local anesthesia, volume and concentration of LA and the applied assistive technique (ultrasound or nerve stimulator). For both this reason and due to the high variability in the PI values, the PI ratio was calculated to predict block success.
Measured: Up to 6 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start15 Apr 2014
- Primary completion15 Apr 2014
- Study completion30 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921891
- Sponsor's protocol ID
- 2014-86
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Block Success in Patients Undergoing Ultrasound-guided Infraclavicular Brachial Plexus Block With Bilateral Upper Extremity Perfusion Index
- ClinicalTrials.gov ID
- NCT04921891
- Acronym / sponsor ID
- 2014-86
- Conditions
- Carpal Tunnel Syndrome, Perfusion Index
- Keywords
- Infraclavicular block, Perfusion index, Ultrasonography, Block assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 15 Apr 2014 (actual)
- Study completion
- 30 Oct 2014 (actual)
- First posted
- 10 Jun 2021 (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.
The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.
Detailed description
Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Blocked arm | Active comparator | Procedure: Infraclavicular nerve blockThe investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia. |
| Unblocked arm | Active comparator | Procedure: Without nerve blockThe upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages of 18-75
- Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
- ASA I-II-III patients
Key exclusion criteria (6 listed)
- Patients who will refuse this method
- Neurological deficits,
- Diabetes mellitus,
- Local anesthetic allergy,
- Morbidly obese,
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 |
|---|---|---|
| Infraclavicular nerve blockThe investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia. | Procedure or surgery | Blocked arm |
| Without nerve blockThe upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities. | Procedure or surgery | Unblocked arm |
Primary outcome
Evaluation of whether perfusion index is a reliable and objective method to indicate block success
Time frame: 6 hours postprocedurly
Perfusion index was measured up to 6 hours after the procedure.
1 secondary outcome
Determining of a cut-off value for PI and PI ratio for a successful block.
Time frame: Up to 6 hours after the procedure
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 10 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Infraclavicular nerve block and Without nerve block in people with Carpal Tunnel Syndrome and Perfusion Index, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 10 Jun 2021. 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?
Evaluation of whether perfusion index is a reliable and objective method to indicate block success (time frame: 6 hours postprocedurly). 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 10 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.