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

NCT03885804 | Completed Early Phase 1

• 1 other identifier: FMASU R 06/ 2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Keywords

quadratus - dexmedetomidine- bupivavaine- perineural

Outcome Measures

Primary Outcomes (1)

• Total dose of morphine consumption

  mg/kg

  24 hours

Secondary Outcomes (3)

• recovery time

  15-24 minutes

• Ramsay sedation scores

  24 hours postoperative

• incidence of postoperative complications

  24 hours postoperative

Study Arms (2)

Quadratus lamborum dexmedetomidine intravenous group

SHAM COMPARATOR

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

Quadratus lamborum dexmedetomidine perineural group

ACTIVE COMPARATOR

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(

Interventions

Quadratus lamborum dexmedetomidine intravenous DRUG

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

Also known as: (QD IV group)

Quadratus lamborum dexmedetomidine intravenous group

Quadratus lamborum dexmedetomidine perineural group( DRUG

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.

Also known as: QD PN group

Quadratus lamborum dexmedetomidine perineural group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Reem Elkabarity

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associte professor of Anesthesia

Model Details: randomisation by concealed envelope method

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: March 20, 2019
• Primary Completion: July 10, 2019
• Study Completion: August 21, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

EG (1)