CClinicalTrials.gg
Status unknownNCT02990702Updated Dec 13, 2016

Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese Patients

A Phase 4 interventional study of Ultrasound guided retroclavicular block and Ultrasound guided coracoid infraclavicular block in Forearm Injuries and Hand Injuries, sponsored by Kahramanmaras Sutcu Imam University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-13.

Sponsored by Kahramanmaras Sutcu Imam University · Phase 4 and Interventional

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.

Read the detailed description

Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population.

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Conditions studied

  • Forearm Injuries
  • Hand Injuries

Keywords

  • Infraclavicular block
  • Retroclavicular block
  • Ultrasound
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 60 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-80 years
  • BMI>30
  • Forearm- Hand surgery

Exclusion criteria

Exclusion Criteria:

  • \<18 years
  • Local infection
  • Coagulopaty
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Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Ultrasound guided retroclavicular block

    Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine

    Other: Ultrasound guided retroclavicular block · Other: Ultrasound guided coracoid infraclavicular block · Drug: Bupivacaine · Device: Ultrasound

  • Active comparator
    Ultrasound guided infraclavicular block

    Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine

    Other: Ultrasound guided retroclavicular block · Other: Ultrasound guided coracoid infraclavicular block · Drug: Bupivacaine · Device: Ultrasound

Interventions

  • OtherUltrasound guided retroclavicular block

    Ultrasound guided retroclavicular block for forearm or hand surgery

    Also known as: Group R

  • OtherUltrasound guided coracoid infraclavicular block

    Ultrasound guided infraclavicular block for forearm or hand surgery

    Also known as: Group C

  • DrugBupivacaine
  • DeviceUltrasound
06

What researchers measure

Primary outcomes

  1. Technique duration

    The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.

    Time frame: Measured directly during the procedure with a chronometer.

  2. Surgery completion under regional block

    Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for a rescue technique.

    Time frame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed

Secondary outcomes

  1. Sensorial block progression

    Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion. The scale used is: 0:no sensitive block, 1:analgesia (loss of pain but not tactile sensation), 2:anesthesia (loss of pain and tactile sensation).

    Time frame: Assessed 10, 20 and 30 minutes after block completion

  2. Motor Block Progression

    Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion. The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale.

    Time frame: Assessed 10, 20, 30 minutes after the block completion

  3. Needle visualization

    Procedures will be recorded and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good)

    Time frame: Assessed one week after study completion

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02990702
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Bora Bilal (Assistant Proffesor, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Dec 13, 2016
Start date
Jan 2017
Primary completion
May 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Dec 13, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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