Congenital Muscular TorticollisPhase 4NCT02651311
Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis
A Phase 4 study testing intermediate cervical plexus block, Fentanyl and Ibuprofen in people with Congenital Muscular Torticollis, run by Ajou University School of Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Congenital Muscular Torticollis
- What is being tested?
- intermediate cervical plexus block, Fentanyl and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2016to 15 Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II
- Undergoing general anesthesia for unipolar sternocleidomastoid release in patient with congenital muscular torticollis
Who cannot join
- coagulation disorder
- kidney or liver disease
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University School of Medicine
Suwon, Gyeonggi-do, 16499
About this study
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
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
- Medical subject headings
- Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermediate cervical plexus blockOther
Also called ultrasound guided intermediate cervical plexus block
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg
FentanylDrug
fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.
IbuprofenDrug
ibuprofen in ward when more or equal to FLACC scale 4.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fentanyl; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the FLACC scale
Measured: at 5 min after postanesthesia care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start16 Jan 2016
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Muscular TorticollisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
- Investigators
- yun jeong chae, Ph.D, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651311
- Sponsor's protocol ID
- MED-DRU-15-002
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29781932
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02651311
- Acronym / sponsor ID
- MED-DRU-15-002
- Conditions
- Congenital Muscular Torticollis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 16 Jan 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Other: intermediate cervical plexus block, Drug: Fentanyl, Drug: Ibuprofenultrasound 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 | Placebo comparator | Drug: Fentanyl, Drug: IbuprofenFentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I-II
- Undergoing general anesthesia for unipolar sternocleidomastoid release in patient with congenital muscular torticollis
Key exclusion criteria (3 listed)
- coagulation disorder
- kidney or liver disease
- allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermediate cervical plexus blockAlso: ultrasound guided intermediate cervical plexus blockultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg | Other | Block |
| Fentanylfentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4. | Drug | Block, No block |
| Ibuprofenibuprofen in ward when more or equal to FLACC scale 4. | Drug | Block, No block |
Primary outcome
Pain on the FLACC scale
Time frame: at 5 min after postanesthesia care unit admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Derived from this study: PubMed 29781932Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yun jeong chae, Ph.D principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intermediate cervical plexus block, Fentanyl and Ibuprofen in people with Congenital Muscular Torticollis, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on the FLACC scale (time frame: at 5 min after postanesthesia care unit admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.