Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P50-P75 for phase_4

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2016

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

May 16, 2016

Last Update Submit

May 19, 2016

Conditions

Dose-Response Relationship, Drug

Outcome Measures

Primary Outcomes (3)

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%
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
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
up to 12 hours after brachial plexus blocks

Secondary Outcomes (3)

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