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Trial record 99 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

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ClinicalTrials.gov Identifier: NCT02651311
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
yun jeong chae, 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.

Condition or disease Intervention/treatment Phase
Congenital Muscular Torticollis Other: intermediate cervical plexus block Drug: Fentanyl Drug: Ibuprofen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 16, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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.




Primary Outcome Measures :
  1. Pain on the FLACC scale [ Time Frame: at 5 min after postanesthesia care unit admission ]


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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651311


Locations
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Korea, Republic of
Ajou University School of Medicine
Suwon, Gyeong-gi, Korea, Republic of, 16499
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: yun jeong chae, Ph.D Ajou University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: yun jeong chae, Associate Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02651311     History of Changes
Other Study ID Numbers: MED-DRU-15-002
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
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Dystonic Disorders
Dystonia
Torticollis
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Ibuprofen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action