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

Not yet recruiting

• Conditions: Smoking, Cigarette; Regional Anesthesia

• Registration Number: NCT06755229
• Lead Sponsor: Selcuk University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Study Start: 2025-01-15
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensory blockade onset time	During procedure	The sensory blockade onset time will be evaluated using a cold ice pack.

Secondary Outcome Measures

Name	Time	Method
Duration of sensory blockade	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.
Duration of motor blockade	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.
Motor blockade onset time	During procedure	The motor blockade onset time will be assessed by movement at the elbow, wrist and fingers using a modified Bromage scale.
Time to need for postoperative first rescue analgesia	During the postoperative 24-hour period.	The Visual Analogue Scale (VAS) \> 3
Consumption of rescue analgesia	During the postoperative 24-hour period.	The Visual Analogue Scale (VAS) \> 3
Postoperative pain	within the first 24 hours (2, 4, 8, 12, 16, and 24 hours).	Postoperative pain was evaluated with a visual analogue scale