Impact of Smoking on Ultrasound-Guided Infraclavicular Brachial Plexus Block Onset and Duration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Smoking, Cigarette, Regional Anesthesia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Smoking Affect the Onset and Duration of Ultrasound-guided Infraclavicular Brachial Plexus Block?
Overview
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.
Primary outcome measures
- Sensory blockade onset time [Time frame: During procedure]
Secondary outcome measures (6)
- 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).]
Eligibility criteria
Inclusion criteria
- ASA physical status I and II
- Scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block
Exclusion criteria
- morbid obesity (body mass index > 40)
- bleeding disorder
- coagulopathy
- medication with vitamin K antagonists
- high-dose or fractionated heparin treatment
- allergy to local anaesthetics
- infection at the site of needle insertion
- peripheral neurological disease
- pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06755229 · 2024-12-2