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Perineural Versus IV Dexmedetomidine as Adjuvant to Quadratus Lamborum Block for Pediatrics Undergoing Pyeloplasty

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: NCT03885804
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hoda Shokri, Ain Shams University

Brief Summary:
this prospective parallel group double blinded study will be conducted over 50 pediatric patients ASA (American Association of Anesthesiologists) I and II between the age of 8-13 years old,who will be scheduled for laparoscopic pyeloplasty.Patients will be randomly allocated into 2 study groups: Quadratus lamborum dexmedetomidine intravenous group(QD IV group) and Quadratus lamborum dexmedetomidine perineural group(QD PN group.Patients in both groups will receive quadratus lamborum block .In QD IV group a bolus of 0.5 ml/Kg bupivacaine 0.25% in addition to 2ml normal saline will be injected then dexmedetomidine.1ml/kg loading dose will be given over 10 min followed by 0.5 ml/kg/h infusion maintenance dose till the end of surgery. In QD PN, patients will receive perineural dexmedetomidine of 1μ g/kg diluted to 2 mL with 0.9% saline added to 0.5 ml/kg of 0.25% bupivacaine in addition to saline infusion 1ml/kg IV loading dose followed by by 0.5 ml/kg/h infusion maintenance dose till the end of surgery.Time to first analgesic requirement ( primary outcome) , Wong-Baker FACES Pain Rating Scale scores will be recorded at 2, 6, 8,12, 18 and 24h postoperatively, the degree of sedation will be assessed by Ramsay sedation scores(fig.2)(9) at the same time points, hemo-dynamics as systolic and diastolic blood pressures and heart rates will be recorded at PACU discharge then 4 hourly, total dose of morphine consumption, , the length of hospital stay, incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Quadratus lamborum dexmedetomidine intravenous Drug: Quadratus lamborum dexmedetomidine perineural group( Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomisation by concealed envelope method
Masking: Double (Participant, Outcomes Assessor)
Masking Description: a physician assessing outcomes blinded to the nature of the study as first and second rescue analgesics respectively.Drug packs will be prepared before commencement of the study by a pharmacist unaware of the nature of the study
Primary Purpose: Prevention
Official Title: Efficacy of Perineural Versus Intravenous Dexmedetomidine as an Adjuvant to Quadratus Lamborum Block for Pediatrics Undergoing Laparoscopic Pyeloplasty. A Prospective Randomized Double Blinded Study
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : August 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Quadratus lamborum dexmedetomidine intravenous group
Patients will receive quadratus lamborum block on the same surgical side.a bolus of 0.5 ml/Kg bupivacaine 0.25% in addition to 2ml normal saline will be injected then dexmedetomidine (precedex 200 micrograms per 2ml, Abbott laboratories, Abbott park, IL, USA) which will be prepared in concentration 1μg/ml. 1ml/kg loading dose will be given over 10 min followed by 0.5 ml/kg/h infusion maintenance dose till the end of surgery
Drug: Quadratus lamborum dexmedetomidine intravenous
Patients will receive quadratus lamborum block on the same surgical side then a bolus of 0.5 ml/Kg bupivacaine 0.25% in addition to 2ml normal saline will be injected then dexmedetomidine (precedex 200 micrograms per 2ml, Abbott laboratories, Abbott park, IL, USA) which will be prepared in concentration 1μg/ml. 1ml/kg loading dose will be given over 10 min followed by 0.5 ml/kg/h infusion maintenance dose till the end of surgery
Other Name: (QD IV group)

Active Comparator: Quadratus lamborum dexmedetomidine perineural group
Patients will receive quadratus lamborum block on the same surgical side. Patients will receive perineural dexmedetomidine of 1μ g/kg diluted to 2 mL with 0.9% saline added to 0.5 ml/kg of 0.25% bupivacaine in addition to saline infusion 1ml/kg IV loading dose followed by by 0.5 ml/kg/h infusion maintenance dose till the end of surgery.
Drug: Quadratus lamborum dexmedetomidine perineural group(
Patients will receive quadratus lamborum block on the same surgical side then1μ g/kg diluted to 2 mL with 0.9% saline added to 0.5 ml/kg of 0.25% bupivacaine in addition to saline infusion 1ml/kg IV loading dose followed by by 0.5 ml/kg/h infusion maintenance dose till the end of surgery.
Other Name: QD PN group




Primary Outcome Measures :
  1. Total dose of morphine consumption [ Time Frame: 24 hours ]
    mg/kg


Secondary Outcome Measures :
  1. recovery time [ Time Frame: 15-24 minutes ]
    The elapsed time for the patient to open his eyes upon command after discontinuation of Isoflurane

  2. Ramsay sedation scores [ Time Frame: 24 hours postoperative ]

    Ramsay Sedation Scale

    1 Anxious or restless or both Unacceptable; increase sedation 2 Cooperative, orientated and tranquil Acceptable; no action necessary 3 Responding to commands Acceptable; no action necessary 4 Brisk response to stimulus Acceptable; no action necessary 5 Sluggish response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 6 No response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3


  3. incidence of postoperative complications [ Time Frame: 24 hours postoperative ]
    Mann Witney test



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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • paediatrics
  • 8-13 years old
  • ASA I-II
  • laparoscopic pyeloplasty

Exclusion Criteria:

  • developmental delay or mental retardation
  • parent refusal
  • history of allergic reactions to local anesthetics
  • infection at the injection site bleeding disorders history of cardiac, neurological, impaired renal function defined by s-creatinine >150 μmol/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885804


Locations
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Egypt
Ain shams university
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Reem Elkabarity Ain Shams University
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Responsible Party: Hoda Shokri, Associte professor of Anesthesia, Ain Shams University
ClinicalTrials.gov Identifier: NCT03885804    
Other Study ID Numbers: FMASU R 06/ 2019
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after discussion with other authors, the study protocol, statistical analysis and informed consent will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 4-6 months
Access Criteria:

The collected data will be coded, tabulated, and statistically analysed using PASS program setting alpha error at 5% and power at 95%,.

Descriptive statistics will be carried out for numerical parametric data and presented as mean±SD, whereas categorical data will be presented as number and percentage. Variables such as demographic data and comorbidities will be compared using the χ2-test. A P value less than 0.05 will be considered significant Requests will be reviewed by authors


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoda Shokri, Ain Shams University:
quadratus - dexmedetomidine- bupivavaine- perineural
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexmedetomidine
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