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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Brief Summary

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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

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Detailed Description

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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

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Dose-Response Relationship, Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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saline (Group A)

perineural ropivacaine

Group Type ACTIVE_COMPARATOR

perineural dexmedetomidine

Intervention Type DRUG

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).

0.5 mcg/kg dexmedetomidine (Group B)

(perineural ropivacaine plus 0.5 mcg/kg dexmedetomidine),

Group Type ACTIVE_COMPARATOR

perineural dexmedetomidine

Intervention Type DRUG

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).

1 mcg/kg dexmedetomidine (Group C)

(perineural ropivacaine plus 1 mcg/kg dexmedetomidine)

Group Type ACTIVE_COMPARATOR

perineural dexmedetomidine

Intervention Type DRUG

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).

1.5 mcg/kg dexmedetomidine (Group D)

(perineural ropivacaine plus 1.5mcg/kg dexmedetomidine)

Group Type ACTIVE_COMPARATOR

perineural dexmedetomidine

Intervention Type DRUG

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).

2 mcg/kg dexmedetomidine (Group E)

(perineural ropivacaine plus 2 mcg/kg dexmedetomidine)

Group Type ACTIVE_COMPARATOR

perineural dexmedetomidine

Intervention Type DRUG

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).

Interventions

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perineural dexmedetomidine

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No