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Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Primary Purpose

Congenital Muscular Torticollis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intermediate cervical plexus block
Fentanyl
Ibuprofen
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Muscular Torticollis

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Block

No block

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Pain on the FLACC scale

Secondary Outcome Measures

Full Information

First Posted
January 7, 2016
Last Updated
January 26, 2017
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02651311
Brief Title
Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 16, 2016 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Muscular Torticollis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Block
Arm Type
Experimental
Arm Description
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.
Arm Title
No block
Arm Type
Placebo Comparator
Arm Description
Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
Intervention Type
Other
Intervention Name(s)
intermediate cervical plexus block
Other Intervention Name(s)
ultrasound guided intermediate cervical plexus block
Intervention Description
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
ibuprofen in ward when more or equal to FLACC scale 4.
Primary Outcome Measure Information:
Title
Pain on the FLACC scale
Time Frame
at 5 min after postanesthesia care unit admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yun jeong chae, Ph.D
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University School of Medicine
City
Suwon
State/Province
Gyeong-gi
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29781932
Citation
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.
Results Reference
derived

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Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

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