Dose-Response Relationship, DrugPhase 4NCT02781246

Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial

A Phase 4 study testing perineural dexmedetomidine in people with Dose-Response Relationship, Drug, run by Guangzhou Women and Children's Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Dose-Response Relationship, Drug
What is being tested?: perineural dexmedetomidine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: Sep 2016to Dec 2017
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 2 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

ASA I,II children, aged between 2 and 6 years, who were scheduled for arm and forearm surgery underwent supraclavicular brachial plexus blocks.

Who cannot join

any subjects with neurological, neuromuscular, psychiatric, or blood clotting disorders, or known history of active and severe renal, hepatic, respiratory, or cardiac diseases, or known allergy to systemic or local anesthetics or dexmedetomidine

About this study

Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric patients has not been investigated. This study was designed to determine the effect of perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients

Read the detailed description

150 children scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine guided by ultrasound visualisation were randomly assigned to one of the five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). The primary endpoint was the minimum local anesthetic concentration (MLAC), which was determined using the Dixon up-and-down method. The secondary endpoints were the duration of analgesia and sedation

Conditions: Dose-Response Relationship, Drug
Being tested: perineural dexmedetomidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

perineural dexmedetomidineDrug
Children scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine and dexmedetomidine guided by ultrasound visualisation were randomly assigned five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). In each group, children received a certain concentration of ropivacaine which adjusted by the "Dixon up-and-down method for supraclavicle brachial plexus. The first child received 0.2% ropivacaine , and the concentration of ropivacaine varied by 0.1% according to the up-and-down method. The primary endpoint was the minimum local anesthetic concentration (MLAC).

Study groups in NCT02781246
Study group	Role	What they receive
saline (Group A)	Active comparator	perineural ropivacaine Receives: Drug: perineural dexmedetomidine
0.5 mcg/kg dexmedetomidine (Group B)	Active comparator	(perineural ropivacaine plus 0.5 mcg/kg dexmedetomidine), Receives: Drug: perineural dexmedetomidine
1 mcg/kg dexmedetomidine (Group C)	Active comparator	(perineural ropivacaine plus 1 mcg/kg dexmedetomidine) Receives: Drug: perineural dexmedetomidine
1.5 mcg/kg dexmedetomidine (Group D)	Active comparator	(perineural ropivacaine plus 1.5mcg/kg dexmedetomidine) Receives: Drug: perineural dexmedetomidine
2 mcg/kg dexmedetomidine (Group E)	Active comparator	(perineural ropivacaine plus 2 mcg/kg dexmedetomidine) Receives: Drug: perineural dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

the minimum local anesthetic concentration (MLAC)
For each patient, the target concentration of perineural ropivacaine was determined using the modified Dixon's up-and-down method starting with 0.20% in each group, varied with 0.1% as a step size. Increasing or decreasing the target concentration of perineural ropivacaine was determined by the response of the previous child in the same group. The response of each child was observed for 60 s after the skin incision and evaluated as 'successful' or 'unsuccessful.' 'Unsuccessful' was recorded when skin incision caused motor responses or change in hemodynamic parameters (heart rate and mean blood pressure) more than 20% of the preincision values. If the response was determined to be unsuccessful, the concentration of perineural ropivacaine given to the next patient would be increased by 0.1%. If it was successful, the concentration of caudal levobupivacaine given to the next patient would be decreased by 0.1%
Measured: up to 30 minutes after brachial plexus blocks
Postoperative pain
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.
The scale is scored in a range of 0-10 with 0 representing no pain, 1-3 representing mild uncomfortable, 4-6 representing moderate pain, 7-10 representing high-level pain or/and uncomfort. The FLACC scale was evaluated at 6 and 12 hours postoperatively, and scale of ≥4 points was regarded as an inadequate analgesia and was managed with 10 mg/kg of ibuprofen by mouth every 6 h as required
Measured: up to 12 hours after brachial plexus blocks
The sedation status
Sedation status was evaluated by a attending anesthesiologists with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S). The MOAA/S scale was evaluated at 6 and 12 hours postoperatively
0 Does not respond to a noxious stimulus
1. Does not respond to mild prodding or shaking
2. Responds only after mild prodding or shaking
3. Responds only after name is called loudly or repeatedly
4. Lethargic response to name-spoken in normal tone
5. Appears asleep, but responds readily to name-spoken in normal tone
6. Appears alert and awake, responds readily to name-spoken in normal tone
Measured: up to 12 hours after brachial plexus blocks

Secondary outcomes (3)

pulse oximetry
Significant Oxyhemoglobin desaturation was defined as < 90%
Measured: up to 12 hours after brachial plexus blocks
heart rate
Bradycardia was defined as a reduction in heart rate more than 20% from the baseline values
Measured: up to 12 hours after brachial plexus blocks
noninvasive arterial blood pressure
Hypotension was defined as a reduction in systolic blood pressure more than 20% from the baseline values
Measured: up to 12 hours after brachial plexus blocks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Dec 2017

First posted24 May 2016 (estimated)
Study startSep 2016
Primary completionDec 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dose-Response Relationship, DrugStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02781246
Sponsor's protocol ID: Wzhang05
Status last verified: May 2016
First submitted: 16 May 2016
Last updated: 24 May 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial
ClinicalTrials.gov ID: NCT02781246
Acronym / sponsor ID: Wzhang05
Conditions: Dose-Response Relationship, Drug
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 160 participants (estimated)
Lead sponsor: Guangzhou Women and Children's Medical CenterUniversity, hospital or other
Study start: Sep 2016
Primary completion: Dec 2017 (estimated)
First posted: 24 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
saline (Group A)	Active comparator	Drug: perineural dexmedetomidineperineural ropivacaine
0.5 mcg/kg dexmedetomidine (Group B)	Active comparator	Drug: perineural dexmedetomidine(perineural ropivacaine plus 0.5 mcg/kg dexmedetomidine),
1 mcg/kg dexmedetomidine (Group C)	Active comparator	Drug: perineural dexmedetomidine(perineural ropivacaine plus 1 mcg/kg dexmedetomidine)
1.5 mcg/kg dexmedetomidine (Group D)	Active comparator	Drug: perineural dexmedetomidine(perineural ropivacaine plus 1.5mcg/kg dexmedetomidine)
2 mcg/kg dexmedetomidine (Group E)	Active comparator	Drug: perineural dexmedetomidine(perineural ropivacaine plus 2 mcg/kg dexmedetomidine)

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

ASA I,II children, aged between 2 and 6 years, who were scheduled for arm and forearm surgery underwent supraclavicular brachial plexus blocks.

Key exclusion criteria (1 listed)

any subjects with neurological, neuromuscular, psychiatric, or blood clotting disorders, or known history of active and severe renal, hepatic, respiratory, or cardiac diseases, or known allergy to systemic or local anesthetics or dexmedetomidine

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
perineural dexmedetomidineChildren scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine and dexmedetomidine guided by ultrasound visualisation were randomly assigned five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). In each group, children received a certain concentration of ropivacaine which adjusted by the "Dixon up-and-down method for supraclavicle brachial plexus. The first child received 0.2% ropivacaine , and the concentration of ropivacaine varied by 0.1% according to the up-and-down method. The primary endpoint was the minimum local anesthetic concentration (MLAC).	Drug	0.5 mcg/kg dexmedetomidine (Group B), 1 mcg/kg dexmedetomidine (Group C), 1.5 mcg/kg dexmedetomidine (Group D), 2 mcg/kg dexmedetomidine (Group E), saline (Group A)

Primary outcome

the minimum local anesthetic concentration (MLAC)
Time frame: up to 30 minutes after brachial plexus blocks
For each patient, the target concentration of perineural ropivacaine was determined using the modified Dixon's up-and-down method starting with 0.20% in each group, varied with 0.1% as a step size. Increasing or decreasing the target concentration of perineural ropivacaine was determined by the response of the previous child in the same group. The response of each child was observed for 60 s after the skin incision and evaluated as 'successful' or 'unsuccessful.' 'Unsuccessful' was recorded when skin incision caused motor responses or change in hemodynamic parameters (heart rate and mean blood pressure) more than 20% of the preincision values. If the response was determined to be unsuccessful, the concentration of perineural ropivacaine given to the next patient would be increased by 0.1%. If it was successful, the concentration of caudal levobupivacaine given to the next patient would be decreased by 0.1%
Postoperative pain
Time frame: up to 12 hours after brachial plexus blocks
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain, 1-3 representing mild uncomfortable, 4-6 representing moderate pain, 7-10 representing high-level pain or/and uncomfort. The FLACC scale was evaluated at 6 and 12 hours postoperatively, and scale of ≥4 points was regarded as an inadequate analgesia and was managed with 10 mg/kg of ibuprofen by mouth every 6 h as required
The sedation status
Time frame: up to 12 hours after brachial plexus blocks
Sedation status was evaluated by a attending anesthesiologists with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S). The MOAA/S scale was evaluated at 6 and 12 hours postoperatively 0 Does not respond to a noxious stimulus 1. Does not respond to mild prodding or shaking 2. Responds only after mild prodding or shaking 3. Responds only after name is called loudly or repeatedly 4. Lethargic response to name-spoken in normal tone 5. Appears asleep, but responds readily to name-spoken in normal tone 6. Appears alert and awake, responds readily to name-spoken in normal tone

3 secondary outcomes

pulse oximetry
Time frame: up to 12 hours after brachial plexus blocks
heart rate
Time frame: up to 12 hours after brachial plexus blocks
noninvasive arterial blood pressure
Time frame: up to 12 hours after brachial plexus blocks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.

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RecruitingObservational study
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RecruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing perineural dexmedetomidine in people with Dose-Response Relationship, Drug, run by Guangzhou Women and Children's Medical Center.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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?

the minimum local anesthetic concentration (MLAC) (time frame: up to 30 minutes after brachial plexus blocks). The study lists 3 primary outcomes in all. 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 NCT02781246.

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 24 May 2016.