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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking, Cigarette; Regional Anesthesia

• Study Type: Observational
• Enrollment (Estimated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-smoker; Never smoked in their life
Smoker; ≥20 cigarettes/day for>1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory blockade onset time	The sensory blockade onset time will be evaluated using a cold ice pack.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	During procedure
Time to need for postoperative first rescue analgesia	The Visual Analogue Scale (VAS) > 3	During the postoperative 24-hour period.
Consumption of rescue analgesia	The Visual Analogue Scale (VAS) > 3	During the postoperative 24-hour period.
Postoperative pain	Postoperative pain was evaluated with a visual analogue scale	within the first 24 hours (2, 4, 8, 12, 16, and 24 hours).

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-12-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No