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Retroclavicular Approach to Infraclavicular Block

A

Antalya Training and Research Hospital

Status

Completed

Conditions

Bupivacaine

Treatments

Other: minimum effective volume

Study type

Observational

Funder types

Other

Identifiers

NCT03472911
AntalyaTRH 20

Details and patient eligibility

About

In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Full description

Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.

Enrollment

25 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
  • American Society of Anesthesiologists class I, II or III

Exclusion criteria

  • patients <18 years old
  • >65 years old
  • body mass index (BMI) <20 or >35 kg/m2
  • inability to provide written informed consent
  • refusal of regional anesthesia
  • pregnancy
  • contraindication for regional anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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