Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.

Dexmedetomidine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089932
• Other study ID #: N-60-2013
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Knee Surgery
• Dexmedetomidine
• Femoral Nerve Block

Intervention

Drug:
• peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block
ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally. After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia.
• Placebo

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of sensory block	the time interval between the onset of the sensory block and the complete resolution of normal sensation. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of normal sensation; a blinded investigator will assess sensory block with pinprick test using a 3-point scale: 0 - complete loss of sensation, 1 - partial loss of sensation and 2 - normal sensation. Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve.	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	Time to first request of postoperative rescue analgesic	the time interval between the onset of successful sensory block and the first request to postoperative analgesia	over the first postoperative 24hours
Secondary	Onset of sensory block	the time elapsed between the end of injection and the development of complete sensory block	up to 30 minutes after the end of injection
Secondary	Onset of motor block	the time elapsed between the end of injection and the development of complete motor block	up to 30 minutes after the end of injection
Secondary	visual analogue pain scores (VAS)	Visual analogue pain scores (resting and dynamic VAS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.	2hours post operative and for 24hours
Secondary	Richmond Agitation-Sedation Score (RASS)	Richmond Agitation-Sedation Score (RASS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.	2hours post operative and for 24hours
Secondary	duration of motor block	The time interval between the onset of the motor block and the complete resolution of the motor power in quadriceps muscle. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of motor power; a blinded investigator will assess the motor block using a 3-point scale where: 0 - no movement, 1 - reduced motor strength, but some perceptible movement, and 2 - normal motor function.	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.
Secondary	total morphine consumption	The total dose of morphine needed by the patient postoperatively till 24 hours.	The first 24 hours postoperatively
Secondary	perioperative hemodynamic parameters	Vital signs (heart rate and arterial blood pressure) 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.	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.
Secondary	incidence of side effects.	Adverse events will be defined as hypotension (a 30% decrease in systolic blood pressure in relation to the baseline value), bradycardia (heart rate less than 60 beats per minute), desaturation (SpO2 < 90% on room air) and postoperative nausea and/or vomiting.	from the injection time till 24 hours postoperatively