Clinical trial NCT02089932: Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
Official title: The Effects of Different Dose Levels of Peri-neural Dexmedetomidine on the Pharmacodynamic and Side Effects Profiles of Bupivacaine-induced Ultrasound-guided Femoral Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dexmedetomidine
Femoral Nerve Block
Arthroscopic Knee Surgery
Keywords: femoral nerve block
peri-neural dexmedetomidine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine in different dose levels as adjuvant to local anesthetic was not previously reported for femoral nerve block.


Eligibility criteria: Inclusion Criteria:

* all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery

Exclusion Criteria:

* Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications

Primary outcomes:
measure: duration of sensory block
timeFrame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of normal sensation.
Secondary outcomes:
measure: Time to first request of postoperative rescue analgesic
timeFrame: over the first postoperative 24hours
measure: Onset of sensory block
timeFrame: up to 30 minutes after the end of injection
measure: Onset of motor block
timeFrame: up to 30 minutes after the end of injection
measure: visual analogue pain scores (VAS)
timeFrame: 2hours post operative and for 24hours
measure: Richmond Agitation-Sedation Score (RASS)
timeFrame: 2hours post operative and for 24hours
measure: duration of motor block
timeFrame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of motor power.
measure: total morphine consumption
timeFrame: The first 24 hours postoperatively
measure: perioperative hemodynamic parameters
timeFrame: will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.
measure: incidence of side effects.
timeFrame: from the injection time till 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy
Study officials:
affiliation: Cairo University
name: Mohamed Abdulatif, Professor of Anesthesia
role: STUDY_CHAIR
References: