Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Phase 4

Completed

• Conditions: Congenital Muscular Torticollis
• Interventions: Other: intermediate cervical plexus block; Drug: Fentanyl; Drug: Ibuprofen

• Registration Number: NCT02651311
• Lead Sponsor: Ajou University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-01-16
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block	intermediate cervical plexus block	ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg. Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
Block	Fentanyl	ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg. Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
No block	Fentanyl	Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
Block	Ibuprofen	ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg. Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
No block	Ibuprofen	Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.

Primary Outcome Measures

Name	Time	Method
Pain on the FLACC scale	at 5 min after postanesthesia care unit admission

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Gyeong-gi, Korea, Republic of