Smoking, CigaretteNCT06755229
Impact of Smoking on Ultrasound-Guided Infraclavicular Brachial Plexus Block Onset and Duration
An observational study of Smoking, Cigarette and Regional Anesthesia, run by Selcuk University.
Trial summary
The present study will be conducted involving 40 patients aged 18-65 years with ASA physical status I and II, scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking, Cigarette, Regional Anesthesia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 20 Mar 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients aged 18 to 65 years, classified as ASA physical status I and II, scheduled for acute or elective hand or forearm surgery with a lateral infraclavicular block.
Who may be able to join
- ASA physical status I and II
- Scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block
Who cannot join
- morbid obesity (body mass index > 40)
- bleeding disorder
- coagulopathy
- medication with vitamin K antagonists
- high-dose or fractionated heparin treatment
- allergy to local anaesthetics
Show all 9Show fewer
- infection at the site of needle insertion
- peripheral neurological disease
- pregnancy
About this study
Official title: Does Smoking Affect the Onset and Duration of Ultrasound-guided Infraclavicular Brachial Plexus Block?
The present study will be conducted involving 40 patients aged 18-65 years with ASA physical status I and II, scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block. Patients will be divided into two groups based on smoking status: Group I (non-smokers) and Group II (smokers who smoke ≥20 cigarettes/day for over 1 year).
Using a high-frequency linear ultrasound transducer, the axillary artery, vein, and the three nerve cords will be identified in the lateral infraclavicular region. After disinfection with ethanol-chlorhexidine, a sterile drape will be placed, and the attending anesthesiologist will perform the ultrasound-guided infraclavicular brachial plexus block with a triple injection technique. A total of 10 mL of bupivacaine 0.25% and prilocaine 0.05% will be injected at all three nerve cords.
The primary outcome will be the sensory blockade onset time, while secondary outcomes will include the duration of sensory and motor blockade, motor blockade onset time, time to first postoperative rescue analgesia, and total consumption of rescue analgesia. Postoperative pain will be assessed using the Visual Analogue Scale (VAS) within the first 24 hours at intervals of 2, 4, 8, 12, 16, and 24 hours. If VAS exceeds 30 cm, rescue analgesia with 0.05 mg/kg intravenous morphine sulfate will be administered.
- Conditions
- Smoking, Cigarette, Regional Anesthesia
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoker | Never smoked in their life | |
| Smoker | ≥20 cigarettes/day for>1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory blockade onset time
The sensory blockade onset time will be evaluated using a cold ice pack.
Measured: During procedure
Secondary outcomes (6)
Duration of sensory blockade
The duration of sensory blockade will be evaluated as the time between the onset of the sensory block and the complete disappearance of the sensory blockade.
Measured: up to 24 hours
Duration of motor blockade
The duration of motor blockade will be evaluated as the time between the onset of the motor block and the achievement of Grade 0 on the modified Bromage scale.
Measured: up to 24 hours
Motor blockade onset time
The motor blockade onset time will be assessed by movement at the elbow, wrist and fingers using a modified Bromage scale.
Measured: During procedure
Time to need for postoperative first rescue analgesia
The Visual Analogue Scale (VAS) > 3
Measured: During the postoperative 24-hour period.
Consumption of rescue analgesia
The Visual Analogue Scale (VAS) > 3
Measured: During the postoperative 24-hour period.
Postoperative pain
Postoperative pain was evaluated with a visual analogue scale
Measured: within the first 24 hours (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.
- First posted1 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet SARGIN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755229
- Sponsor's protocol ID
- 2024-12-2
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Smoking Affect the Onset and Duration of Ultrasound-guided Infraclavicular Brachial Plexus Block?
- ClinicalTrials.gov ID
- NCT06755229
- Acronym / sponsor ID
- 2024-12-2
- Conditions
- Smoking, Cigarette, Regional Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 1 Jan 2025 (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 present study will be conducted involving 40 patients aged 18-65 years with ASA physical status I and II, scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block. Patients will be divided into two groups based on smoking status: Group I (non-smokers) and Group II (smokers who smoke ≥20 cigarettes/day for over 1 year).
Using a high-frequency linear ultrasound transducer, the axillary artery, vein, and the three nerve cords will be identified in the lateral infraclavicular region. After disinfection with ethanol-chlorhexidine, a sterile drape will be placed, and the attending anesthesiologist will perform the ultrasound-guided infraclavicular brachial plexus block with a triple injection technique. A total of 10 mL of bupivacaine 0.25% and prilocaine 0.05% will be injected at all three nerve cords.
The primary outcome will be the sensory blockade onset time, while secondary outcomes will include the duration of sensory and motor blockade, motor blockade onset time, time to first postoperative rescue analgesia, and total consumption of rescue analgesia. Postoperative pain will be assessed using the Visual Analogue Scale (VAS) within the first 24 hours at intervals of 2, 4, 8, 12, 16, and 24 hours. If VAS exceeds 30 cm, rescue analgesia with 0.05 mg/kg intravenous morphine sulfate will be administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-smoker | – | –Never smoked in their life |
| Smoker | – | –≥20 cigarettes/day for>1 year |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 65 years, classified as ASA physical status I and II, scheduled for acute or elective hand or forearm surgery with a lateral infraclavicular block.
Key inclusion criteria (2 listed)
- ASA physical status I and II
- Scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block
Key exclusion criteria (9 listed)
- morbid obesity (body mass index > 40)
- bleeding disorder
- coagulopathy
- medication with vitamin K antagonists
- high-dose or fractionated heparin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory blockade onset time
Time frame: During procedure
The sensory blockade onset time will be evaluated using a cold ice pack.
6 secondary outcomes
Duration of sensory blockade
Time frame: up to 24 hours
Duration of motor blockade
Time frame: up to 24 hours
Motor blockade onset time
Time frame: During procedure
Time to need for postoperative first rescue analgesia
Time frame: During the postoperative 24-hour period.
Consumption of rescue analgesia
Time frame: During the postoperative 24-hour period.
Postoperative pain
Time frame: within the first 24 hours (2, 4, 8, 12, 16, and 24 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, Cigarette and Regional Anesthesia, run by Selcuk University.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 1 Jan 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Sensory blockade onset time (time frame: During procedure). 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 1 Jan 2025.