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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02651311
Other study ID # MED-DRU-15-002
Secondary ID
Status Completed
Phase Phase 4
First received January 7, 2016
Last updated January 26, 2017
Start date January 16, 2016
Est. completion date December 15, 2016

Study information

Verified date January 2017
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 15, 2016
Est. primary completion date December 15, 2016
Accepts healthy volunteers No
Gender All
Age group 1 Year to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
intermediate cervical plexus block
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg
Drug:
Fentanyl
fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.
Ibuprofen
ibuprofen in ward when more or equal to FLACC scale 4.

Locations

Country Name City State
Korea, Republic of Ajou University School of Medicine Suwon Gyeong-gi

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain on the FLACC scale at 5 min after postanesthesia care unit admission
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Recruiting NCT03562260 - Bipolar Surgical Release in Congenital Muscular Torticollis N/A