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

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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Arthroscopic Knee Surgery; Femoral Nerve Block
• Intervention / Treatment: Drug: Placebo; Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Al Ainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group B: control bupivacaine group; Patient in this group will receive 25 ml bupivacaine 0.5% plus 1 ml normal saline peri-neurally	Drug: Placebo; 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.
Experimental: Group B-DEX 25 : Peri-neural Dexmedetomidine; Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (25 microgram) Dexmedetomidine peri-neurally	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.
Experimental: Group B-DEX 50:Peri-neural Dexmedetomidine; Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (50 microgram) Dexmedetomidine peri-neurally	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.
Experimental: Group B-DEX 75:Peri-neural Dexmedetomidine; Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (75microgram) Dexmedetomidine peri-neurally	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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.
total morphine consumption	The total dose of morphine needed by the patient postoperatively till 24 hours.	The first 24 hours postoperatively
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.
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed Abdulatif, Professor of Anesthesia, Cairo University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 16, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: femoral nerve block; peri-neural dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: N-60-2013