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Completed

NCT Number: NCT07827300

Ultrasound-Guided Assessment of Ventrogluteal Intramuscular Injection in Adults With High BMI

This study evaluated the ventrogluteal site for intramuscular injection in adults with a body mass index of 25 kg/m² or higher. Ultrasound was used to measure subcutaneous tissue, muscle, and total tissue thickness at the injection site and the distances from the injection point to anatomical landmarks and the sciatic nerve. During intramuscular injection with a 40 mm needle, real-time ultrasound was used to visualize the needle tip and assess its position within the muscle. The study also evaluated successful intramuscular placement, subcutaneous medication leakage, and injection-related complications. The findings were assessed across three body mass index groups.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bagcilar Training and Research Hospital

Istanbul, Eyalet/Yerleşke, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 and <75 years.
  • Body mass index >24.9 kg/m².
  • A clinical order for intramuscular administration of 1 mL cyanocobalamin at a concentration of 1000 mcg/mL.
  • No muscle atrophy or motor or sensory loss associated with neurological or muscular pathology.
  • Able to walk independently or with assistance and perform activities of daily living.

Exclusion criteria

  • Degenerative muscle diseases or motor neuron diseases.
  • Amyotrophic lateral sclerosis or other progressive neuromuscular diseases.
  • Severe muscle atrophy or motor function loss that could affect the reliability of ultrasonographic muscle-thickness measurements.
  • Muscle structure considered unsuitable for reliable ultrasonographic measurement or presence of motor/sensory function loss on clinical evaluation.

Treatment and study plan

Ventrogluteal Intramuscular Injection Using a 40 mm Needle

Procedure

Participants received a ventrogluteal intramuscular injection of 1 mL cyanocobalamin (1000 mcg/mL) using a 40 mm, 21-gauge needle. The injection site was identified using the G method. During the injection, the needle tip was visualized in real time using ultrasonography to evaluate its intramuscular position, including its distance from the superficial muscle fascia and the ilium. The position of the needle tip relative to the sciatic nerve was also assessed.

Primary outcomes

  1. Percentage of Participants With Successful Intramuscular Placement of the 40 mm Needle

    Time frame: During the injection procedure, immediately after full insertion of the needle and before medication administration

    The percentage of participants in whom the 40 mm needle met the predefined intramuscular placement criteria was assessed using real-time ultrasonography. Successful intramuscular placement was defined as the needle tip being at least 10 mm beneath the superficial muscle fascia and at least 10 mm away from the iliac cortex.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Ventrogluteal Intramuscular Injection in Individuals With High Body Mass Index: Ultrasound-Based Anatomical Measurements and Evaluation of Safe Intramuscular Placement of a 40 mm Needle

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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