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

Guangzhou Women and Children's Medical Center

Status and phase: Unknown; Phase 4

Conditions: Dose-Response Relationship, Drug

Treatments: Drug: perineural dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02781246

Wzhang05

Details and patient eligibility

About

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

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 5 patient groups

saline (Group A)

Active Comparator group

Description:

perineural ropivacaine

Treatment:

Drug: perineural dexmedetomidine

0.5 mcg/kg dexmedetomidine (Group B)

Active Comparator group

Description:

(perineural ropivacaine plus 0.5 mcg/kg dexmedetomidine),

Treatment:

Drug: perineural dexmedetomidine

1 mcg/kg dexmedetomidine (Group C)

Active Comparator group

Description:

(perineural ropivacaine plus 1 mcg/kg dexmedetomidine)

Treatment:

Drug: perineural dexmedetomidine

1.5 mcg/kg dexmedetomidine (Group D)

Active Comparator group

Description:

(perineural ropivacaine plus 1.5mcg/kg dexmedetomidine)

Treatment:

Drug: perineural dexmedetomidine

2 mcg/kg dexmedetomidine (Group E)

Active Comparator group

Description:

(perineural ropivacaine plus 2 mcg/kg dexmedetomidine)

Treatment:

Drug: perineural dexmedetomidine