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

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ClinicalTrials.gov Identifier: NCT02089932
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Heba Nassar,MD, Cairo University

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.

Condition or disease Intervention/treatment Phase
Dexmedetomidine Femoral Nerve Block Arthroscopic Knee Surgery Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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: 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.


Drug: Placebo
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.





Primary Outcome Measures :
  1. duration of sensory block [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Time to first request of postoperative rescue analgesic [ Time Frame: over the first postoperative 24hours ]
    the time interval between the onset of successful sensory block and the first request to postoperative analgesia

  2. Onset of sensory block [ Time Frame: up to 30 minutes after the end of injection ]
    the time elapsed between the end of injection and the development of complete sensory block

  3. Onset of motor block [ Time Frame: up to 30 minutes after the end of injection ]
    the time elapsed between the end of injection and the development of complete motor block

  4. visual analogue pain scores (VAS) [ Time Frame: 2hours post operative and for 24hours ]
    Visual analogue pain scores (resting and dynamic VAS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.

  5. Richmond Agitation-Sedation Score (RASS) [ Time Frame: 2hours post operative and for 24hours ]
    Richmond Agitation-Sedation Score (RASS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.

  6. duration of motor block [ Time Frame: 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. ]
    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.

  7. total morphine consumption [ Time Frame: The first 24 hours postoperatively ]
    The total dose of morphine needed by the patient postoperatively till 24 hours.

  8. perioperative hemodynamic parameters [ Time Frame: 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. ]
    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.

  9. incidence of side effects. [ Time Frame: from the injection time till 24 hours postoperatively ]
    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.



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089932


Locations
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Egypt
Kasr Al Ainy
Cairo, Egypt, 11562
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed Abdulatif, Professor of Anesthesia Cairo University
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Responsible Party: Heba Nassar,MD, lecturer of anesthesia, Cairo University
ClinicalTrials.gov Identifier: NCT02089932    
Other Study ID Numbers: N-60-2013
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Heba Nassar,MD, Cairo University:
femoral nerve block
peri-neural dexmedetomidine
Additional relevant MeSH terms:
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Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action