- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030950
Perineural Dexmedetomidine in Adductor Canal Block
Effects of Peri-neural Dexmedetomidine on the Pharmacodynamic Profile of Bupivacaine-induced Adductor Canal Block in Patients Undergoing Arthroscopic Medial Meniscectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Peripheral nerve blocks using long-acting local anesthetics are commonly utilized as the sole anesthetic technique or as an adjuvant to general anesthesia for post-operative pain management. However, the duration of sensory block after single dose of long acting local anesthetics is not consistently sufficient to avoid the use of postoperative opioids. Many adjuvants were added to local anesthetics to augment the potency and prolong the duration of peripheral nerve blocks. 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. Peri-neural dexmedetomidine was evaluated in animal studies where it prolonged the duration of sensory and motor blocks of local anesthetics without any evidence of neurotoxicity for up to 14 days after initial administration. The effectiveness of perineural dexmedetomidine in augmenting the duration of sensory block of upper limb extremity blocks is based on good quality clinical evidence.
Arthroscopic knee surgery is associated with severe postoperative pain which could be adequately managed by femoral nerve block. However femoral nerve block has been associated with significant motor block and decreased quadriceps muscle strength which may delay ambulation and increase the risk of falling. More recently, adductor canal block (ACB) emerged as a selective motor sparing effective variant of femoral nerve block. Compared with baseline values, the adductor canal block reduces quadriceps muscle strength by 8%, versus 49% for the femoral nerve block. A recent dose finding MRI study reported that 20 ml of local anesthetic is the closest volume to the ED95 for adductor canal block with minimal proximal spread and an estimated success probability of 95.1% (95% credibility interval: 91-98%).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Cairo, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients of aged (18-45), ASA physical status I or II undergoing arthroscopic medial meniscectomy.
Exclusion Criteria:
- Body mass index greater than 35 kg/m2.
- Pregnancy.
- Unstable coronary artery disease, congestive heart failure, or arrhythmias.
- Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
- Pre-existing neurological deficits or neuropathy.
- Significant psychiatric or cognitive conditions interfering with consent or assessment.
- Significant renal or hepatic impairment;
- Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
- Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
- Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexmedetomidine group
Adductor canal block will be performed before induction of general anesthesia.
Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe.
The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle.
The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery.
20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected.
The study solution will be injected underneath the fascia of sartorius muscle.
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to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block
Other Names:
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Placebo Comparator: Control group
Adductor canal block will be performed before induction of general anesthesia.
Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe.
The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle.
The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery.
20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected.
The study solution will be injected underneath the fascia of sartorius muscle.
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to give normal saline to the other group as a placebo
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of analgesia
Time Frame: 24 hours
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the time passed till the patient first analgesic request
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
richmond agitation sedation scale
Time Frame: 24 hours
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A scale to assess the patient sedation and agitation
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24 hours
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duration of sensory block
Time Frame: 24 hours
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The time needed to regain the patient sensation
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24 hours
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onset of sensory block
Time Frame: minutes
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A blinded investigator will assess sensory block with pinprick test every 5 min for 30 min after injection of the study medication using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation.
Assessment will be done in comparison to contra-lateral area
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minutes
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blood pressure
Time Frame: 24 hours
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mmHg
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24 hours
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heart rate
Time Frame: 24 hours
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beat per minutes
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24 hours
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onset of motor block (by assessment of quadriceps muscle strength)
Time Frame: minutes
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The maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle will be measured using a handheld dynamometer
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minutes
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resting visual analogue score
Time Frame: 24 hours
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the grade of pain during rest as experienced by the patient, rated from 0 to 10
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24 hours
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dynamic visual analogue score
Time Frame: 24 hours
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the grade of pain with movement as experienced by the patient, rated from 0 to 10
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed Abdulatif, Professor, Professor and member of research committee of anesthesia department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- N-31-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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