Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02781246
Recruitment Status : Unknown
Verified May 2016 by Wenhua Zhang, Guangzhou Women and Children's Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 24, 2016
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Wenhua Zhang, Guangzhou Women and Children's Medical Center

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

Condition or disease Intervention/treatment Phase
Dose-Response Relationship, Drug Drug: perineural dexmedetomidine Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: saline (Group A)
perineural ropivacaine
Drug: 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).

Active Comparator: 0.5 mcg/kg dexmedetomidine (Group B)
(perineural ropivacaine plus 0.5 mcg/kg dexmedetomidine),
Drug: 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).

Active Comparator: 1 mcg/kg dexmedetomidine (Group C)
(perineural ropivacaine plus 1 mcg/kg dexmedetomidine)
Drug: 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).

Active Comparator: 1.5 mcg/kg dexmedetomidine (Group D)
(perineural ropivacaine plus 1.5mcg/kg dexmedetomidine)
Drug: 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).

Active Comparator: 2 mcg/kg dexmedetomidine (Group E)
(perineural ropivacaine plus 2 mcg/kg dexmedetomidine)
Drug: 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).




Primary Outcome Measures :
  1. 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%

  2. 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


  3. 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


Secondary Outcome Measures :
  1. pulse oximetry [ Time Frame: up to 12 hours after brachial plexus blocks ]
    Significant Oxyhemoglobin desaturation was defined as < 90%

  2. heart rate [ Time Frame: up to 12 hours after brachial plexus blocks ]
    Bradycardia was defined as a reduction in heart rate more than 20% from the baseline values

  3. noninvasive arterial blood pressure [ Time Frame: up to 12 hours after brachial plexus blocks ]
    Hypotension was defined as a reduction in systolic blood pressure more than 20% from the baseline values



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Wenhua Zhang, Director, Clinical Resesearch, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02781246    
Other Study ID Numbers: Wzhang05
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Dexmedetomidine
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics