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Clinical Trials/NCT06755229
NCT06755229
Not yet recruiting
Not Applicable

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

Selcuk University0 sites40 target enrollmentStarted: January 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Primary Endpoint
Sensory blockade onset time

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Sensory blockade onset time

Time Frame: During procedure

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

Secondary Outcomes

  • Duration of sensory blockade(up to 24 hours)
  • Duration of motor blockade(up to 24 hours)
  • Motor blockade onset time(During procedure)
  • Time to need for postoperative first rescue analgesia(During the postoperative 24-hour period.)
  • Consumption of rescue analgesia(During the postoperative 24-hour period.)
  • Postoperative pain(within the first 24 hours (2, 4, 8, 12, 16, and 24 hours).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet SARGIN

Associate Professor

Selcuk University

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