Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

NCT02651311 | Completed Phase 4

• 1 other identifier: MED-DRU-15-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Muscular Torticollis

Outcome Measures

Primary Outcomes (1)

• Pain on the FLACC scale

  at 5 min after postanesthesia care unit admission

Study Arms (2)

Block

EXPERIMENTAL

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.

Other: intermediate cervical plexus block; Drug: Fentanyl; Drug: Ibuprofen

No block

PLACEBO COMPARATOR

Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.

Drug: Fentanyl; Drug: Ibuprofen

Interventions

intermediate cervical plexus block OTHER

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

Also known as: ultrasound guided intermediate cervical plexus block

Block

Fentanyl DRUG

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

Block; No block

Ibuprofen DRUG

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

Block; No block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (1)

• Kim JS, Joe HB, Park MC, Ahn H, Lee SY, Chae YJ. Postoperative Analgesic Effect of Ultrasound-Guided Intermediate Cervical Plexus Block on Unipolar Sternocleidomastoid Release With Myectomy in Pediatric Patients With Congenital Muscular Torticollis: A Prospective, Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):634-640. doi: 10.1097/AAP.0000000000000797.

  PMID: 29781932 DERIVED

MeSH Terms

Conditions

Congenital torticollis

Interventions

Fentanyl; Ibuprofen

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• yun jeong chae, Ph.D

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 11, 2016
• Study Start: January 16, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

KR (1)