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Clinical trial

Systemic Versus Local Dexamedetomedine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block in Kidney Exploration Surgeries ,A Randomized Controlled Trial

ID
Name
Asw.U./742 /2/23
Description
The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.
Trial arms
Trial start
2023-02-01
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Dexmedetomidine Injection [Precedex]
Group ΙI (group DL): erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexamedetomedine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9% ) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia
Arms:
Group ΙI (group DL):
Bupivacaine Hydrochloride
.Group Ι Block only (group BO) (control group): erector spinae block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia
Arms:
Group Ι Block only (group BO) (control group)
Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)
Group III (group D IV): erector spinea block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexamedetomedine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia.
Arms:
Group III (group D IV):
Size
75
Primary endpoint
The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.
at 60 , 180 minutes
Eligibility criteria
Inclusion Criteria: •. kidney exploration surgeries. * ASA I/II patients. * BMI \<35 Exclusion Criteria: * Getting opioid analgesics prior to surgery. * Local infections at the site where needle for block is to be inserted. * ASAIII/IV. * Pregnancy. * History of drug addiction or alcohol abuse or a psychiatric illness,
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'In our randomized controlled trial, we employed masking (also called blinding) to reduce bias. Participants were unaware of whether they were receiving the intervention or control. Caregivers were instructed not to reveal this information, and outcome assessors who evaluated results were kept separate from intervention delivery.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2024-05-03

1 organization

2 products

2 indications

Organization
Aswan University
Product
Dexmedetomidine
Indication
Paraspinal Muscles Block
Indication
Dexmedetomidine
Product
Bupivacaine