Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

January 26, 2017 updated by: yun jeong chae, Ajou University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeong-gi
      • Suwon, Gyeong-gi, Korea, Republic of, 16499
        • Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: intermediate cervical plexus block
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg
Other Names:
  • ultrasound guided intermediate cervical plexus block
Drug: Fentanyl
fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.
Drug: Ibuprofen
ibuprofen in ward when more or equal to FLACC scale 4.
Placebo Comparator: No block
Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
Drug: Fentanyl
fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.
Drug: Ibuprofen
ibuprofen in ward when more or equal to FLACC scale 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain on the FLACC scale
Time Frame: at 5 min after postanesthesia care unit admission
at 5 min after postanesthesia care unit admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2016

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-DRU-15-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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