Body Mass Index and Outcomes of Ultrasound-Guided Infraclavicular Brachial Plexus Block

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent

About this trial

This study aims to investigate whether body mass index (BMI) is associated with differences in the time needed to perform an ultrasound-guided infraclavicular nerve block and how well the block works. This type of regional anesthesia involves injecting a local anesthetic near the nerves below the collarbone to numb the arm for surgery.

The study will include 100 adults undergoing planned hand, wrist, or forearm surgery at Ankara Bilkent City Hospital. Researchers will compare 50 participants with a BMI below 30 kg/m² and 50 participants with a BMI of 30 kg/m² or higher.

The study will assess the time needed to perform the block, block success, the time until sensation and movement are blocked, and patient satisfaction. Researchers will also examine whether arm circumference and muscle measurements are associated with block outcomes.

This is an observational study. Participants will receive routine anesthesia and surgical care, and their treatment will not be assigned or changed for research purposes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older.

American Society of Anesthesiologists (ASA) physical status I, II, or III.

Scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided infraclavicular brachial plexus block.

Willing to receive regional anesthesia.

Disqualifiers

Known allergy to local anesthetic agents.

Infection at the planned injection site.

Anatomical deformity at the planned block site.

Coagulopathy or active bleeding diathesis.

Trial population

Adults aged 18 years or older with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided infraclavicular brachial plexus block at Ankara Bilkent City Hospital, Türkiye. Eligible patients who provide written informed consent will be enrolled consecutively into two cohorts according to body mass index (BMI): BMI \<30 kg/m² and BMI ≥30 kg/m². A total of 100 participants are planned, with 50 participants in each cohort.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound-guided infraclavicular brachial plexus block

    Procedure/Surgery

    Ultrasound-guided infraclavicular brachial plexus block will be performed as part of routine anesthetic care for elective hand, wrist, or forearm surgery. Local anesthetic will be injected posterior to the axillary artery under ultrasound guidance, with intermittent aspiration. Sensory and motor block development will be assessed for 30 minutes after injection. The same block technique will be used in both BMI cohorts.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Non-obese Group (BMI <30 kg/m²)1 intervention
Group B: Obese Group (BMI ≥30 kg/m²)1 intervention

Trial outcomes

Primary outcomes

1

Infraclavicular Block Performance Time

Time elapsed from the first insertion of the block needle through the skin to completion of the local anesthetic injection, measured in minutes. Preparation and ultrasound imaging before needle insertion are excluded. Block performance time will be compared between participants with BMI \<30 kg/m² and those with BMI ≥30 kg/m².

Time frame
During the preoperative block procedure on the day of surgery, from first block needle insertion to completion of local anesthetic injection.

Secondary outcomes

1

Sensory Block Success at 30 Minutes

The percentage of participants achieving a sensory block sufficient to permit surgery within 30 minutes after completion of the local anesthetic injection. Failure to achieve adequate sensory blockade within this period will be classified as an inadequate block. Success rates will be compared between the BMI \<30 kg/m² and BMI ≥30 kg/m² cohorts.

Time frame
Within 30 minutes after completion of the local anesthetic injection, before surgery.
2

Number of Needle Skin Punctures

Total number of skin punctures made with the block needle during the infraclavicular block procedure. The initial puncture and each subsequent reinsertion after complete withdrawal of the needle from the skin will be counted. Needle redirections without complete withdrawal from the skin will not be counted as additional skin punctures.

Time frame
During the preoperative infraclavicular block procedure on the day of surgery.
3

Number of Needle Redirections

Total number of needle redirections during the infraclavicular block procedure. A redirection is defined as withdrawal and subsequent advancement of the needle along a different trajectory without complete removal from the skin. Initial needle advancement and reinsertion following complete withdrawal from the skin will not be counted as redirections.

Time frame
During the preoperative infraclavicular block procedure on the day of surgery.
4

Patient Satisfaction With Regional Anesthesia

Patient satisfaction with regional anesthesia will be assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater satisfaction.

Time frame
Once during the immediate postoperative recovery period on the day of surgery, when the participant is alert and able to respond.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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