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Completed

NCT Number: NCT02651311

Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at birth or shortly after birth, primarily resulting from unilateral shortening of Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some children, which is accompanied by moderate pain and discomfort. The investigators focused the effectiveness of intermediates cervical plexus block because the dermatome of sensory of cervical plexus block is correlated to that of torticollis. So the effect of analgesia could decrease the use of analgesics.

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Key information

Conditions

Congenital Muscular Torticollis Congenital torticollis

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University School of Medicine

Suwon, Gyeonggi-do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-II
  • Undergoing general anesthesia for unipolar sternocleidomastoid release in patient with congenital muscular torticollis

Exclusion criteria

  • coagulation disorder
  • kidney or liver disease
  • allergy to local anesthetics

Treatment and study plan

intermediate cervical plexus block

Other

ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg

Other names: ultrasound guided intermediate cervical plexus block

Fentanyl

Drug

fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.

Ibuprofen

Drug

ibuprofen in ward when more or equal to FLACC scale 4.

Primary outcomes

  1. Pain on the FLACC scale

    Time frame: at 5 min after postanesthesia care unit admission

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Randomized Controlled Trial of the Postoperative Analgesic Efficacy of Ultrasound Guided Intermediate Cervical Plexus Block for Unipolar Sternocleidomastoid Release in Patient With Congenital Muscular Torticollis

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2016
Registry last updated
Jan 27, 2017

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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