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NCT Number: NCT06755229

Impact of Smoking on Ultrasound-Guided Infraclavicular Brachial Plexus Block Onset and Duration

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensory blockade onset time

    Time frame: During procedure

    The sensory blockade onset time will be evaluated using a cold ice pack.

Secondary outcomes

  1. Duration of sensory blockade

    Time frame: up to 24 hours

    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.

  2. Duration of motor blockade

    Time frame: up to 24 hours

    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.

  3. Motor blockade onset time

    Time frame: During procedure

    The motor blockade onset time will be assessed by movement at the elbow, wrist and fingers using a modified Bromage scale.

  4. Time to need for postoperative first rescue analgesia

    Time frame: During the postoperative 24-hour period.

    The Visual Analogue Scale (VAS) > 3

  5. Consumption of rescue analgesia

    Time frame: During the postoperative 24-hour period.

    The Visual Analogue Scale (VAS) > 3

  6. Postoperative pain

    Time frame: within the first 24 hours (2, 4, 8, 12, 16, and 24 hours).

    Postoperative pain was evaluated with a visual analogue scale

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Does Smoking Affect the Onset and Duration of Ultrasound-guided Infraclavicular Brachial Plexus Block?

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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