Pain, Postoperative Clinical Trial
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
Verified date | November 2019 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | August 21, 2019 |
Est. primary completion date | July 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 13 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total dose of morphine consumption | mg/kg | 24 hours | |
Secondary | recovery time | The elapsed time for the patient to open his eyes upon command after discontinuation of Isoflurane | 15-24 minutes | |
Secondary | Ramsay sedation scores | 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 |
24 hours postoperative | |
Secondary | incidence of postoperative complications | Mann Witney test | 24 hours postoperative |
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