Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Congenital Muscular Torticollis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651311
• Other study ID #: MED-DRU-15-002
• 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
• 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

Related Conditions & MeSH terms

• Congenital Muscular Torticollis
• Torticollis

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