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Analgesic Efficacy of Two Doses of Dexmedetomidine as Adjuncts to Lidocaine for Intravenous Regional Anesthesia

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ClinicalTrials.gov Identifier: NCT03399474
Recruitment Status : Unknown
Verified January 2018 by Ahmed Makhlouf, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Makhlouf, Assiut University

Brief Summary:

Intravenous Regional Anesthesia (IVRA) was first used by August Bier in 1908. This technique is easy to administer, reliable and cost-effective for short surgical procedures of the extremities performed on an ambulatory basis with success rate of approximately 95% - 100% .

Lidocaine becomes the local anesthetic of choice for Intravenous Regional Anesthesia (IVRA) because of the lack of cardiac toxicity and neurotoxicity. But, delayed onset of action, poor muscle relaxation and lack of postoperative analgesia are the major limitations of this technique. Accordingly, many additives have been tried to overcome this problem. Muscle relaxants, ketamine,ketorolac, clonidine and opioids are examples of these adjuvants, and their effects have been studied in detail.

An ideal anesthetic agent for IVRA should have rapid analgesic effect to reduce tourniquet pain and its effects should last longer enough after deflating tourniquet. To achieve this, other drugs including narcotics, nonsteroidal anti-inflammatory drugs, ketorolac, clonidine, nitroglycerin (TNG), dexmedetomidine, magnesium, and neostigmine were used in combination with lidocaine in different studies. This study aims 1- To compare the anesthetic and analgesic efficacy of Dexmedetomidine and lidocaine versus lidocaine only during IVRA (Bier's block) and 2-To compare anesthetic and analgesic efficacy of different doses of dexmedetomidine when used as adjuvants to lidocaine during IVRA (Bier's block).


Condition or disease Intervention/treatment Phase
Limb Deformity Drug: Dexmedetomidine Injection 0.25 ug/kg Drug: Lidocaine Drug: Nalbuphine Drug: Paracetamol Drug: Diclofenac sodium (Voltaren®) Drug: Dexmedetomidine Injection 0.5ug/kg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Analgesic Efficacy of Two Different Doses of Dexmedetomidine as Adjuncts to Lidocaine for Intravenous Regional Anesthesia: Randomized Clinical Trial.
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine only
  1. Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline for intravenous regional anesthesia.
  2. Nalbuphine 5 mg intravenously increments up to 0.1 mg/kg
  3. paracetamol (Perfalgan®) 1gm IV drip
  4. Diclofenac sodium (Voltaren®) 75 mg IM
Drug: Lidocaine
Lidocaine

Drug: Nalbuphine
Nalbuphine

Drug: Paracetamol
paracetamol

Drug: Diclofenac sodium (Voltaren®)
Diclofenac sodium (Voltaren®)

Experimental: 0.5 ug/kg dexmedetomidine
  1. Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline (maximum dose200 mg)+
  2. Dexmedetomidine intravenous in a dose of 0.5 ug/kg ,with the total volume diluted to 40 ml with normal saline 0.9%. The solution will be injected at a rate 20 ml/min for intravenous regional anesthesia.
  3. Nalbuphine 5 mg intravenously increments up to 0.1 mg/kg
  4. Paracetamol (Perfalgan®) 1gm IV drip
  5. Diclofenac sodium (Voltaren®) 75 mg IM .
Drug: Lidocaine
Lidocaine

Drug: Nalbuphine
Nalbuphine

Drug: Paracetamol
paracetamol

Drug: Diclofenac sodium (Voltaren®)
Diclofenac sodium (Voltaren®)

Drug: Dexmedetomidine Injection 0.5ug/kg
Dexmedetomidine 0.5ug/kg

Experimental: 0.25 ug/kg dexmedetomidine

1 Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline (maximum dose200 mg)+ 2- Dexmedetomidine intravenous in a dose of 0.25 ug/kg ,with the total volume diluted to 40 ml with normal saline 0.9%. The solution will be injected at a rate 20 ml/min.for intravenous regional anesthesia.

3-Nalbuphine 5 mg intravenously increments up to 0.1 mg/kg 4- Paracetamol (Perfalgan®) 1gm IV drip 5- Diclofenac sodium (Voltaren®) 75 mg IM

Drug: Dexmedetomidine Injection 0.25 ug/kg
Dexmedetomidine 0.25 ug/kg

Drug: Lidocaine
Lidocaine

Drug: Nalbuphine
Nalbuphine

Drug: Paracetamol
paracetamol

Drug: Diclofenac sodium (Voltaren®)
Diclofenac sodium (Voltaren®)




Primary Outcome Measures :
  1. The time to first analgesic request. [ Time Frame: 24 hours ]
    if patients starts to complain (VAS > 3); rescue analgesia will be given in the form of paracetamol (Perfalgan®) 1gm IV drip and/or diclofenac sodium (Voltaren®) 75 mg IM, and/or nalbuphine 5 mg IV (with maximum daily dose of 2 mg/Kg/day) till VAS ≤ 3.And total amount of nalbuphine administered in first 24 hours to each group will be recorded.


Secondary Outcome Measures :
  1. Pain due to the tourniquet assessed with visual analogue scale (VAS) scores before and after the application of tourniquet and during the operation [ Time Frame: 24 hours ]
    Pain due to the tourniquet will be ssessed with visual analogue scale (VAS) scores (0 = no pain and 10 = worst pain imaginable).

  2. Levels of sedation assessed with the Ramsey sedation scale before and after the application of tourniquet and during the operation [ Time Frame: 24 hours ]
    Levels of sedation will be assessed with the Ramsey sedation scale as follows: 1-patient is anxious and agitated or restless or both, 2-patients is cooperative, oriented and tranquil, 3-patient responds to command only, 4-patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5-patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, and 6-patients exhibits no response .

  3. The onset, duration times of both sensory and motor blocks, Sensory block onset time, Motor block onset time [ Time Frame: 24 hours ]
    Sensory block onset time will be noted as the time elapsed from drug injection to complete sensory block achieved in all dermatomes. Motor block onset time is the time elapsed from injection of study drug to complete motor block.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 20-60 years with American society of anesthesiologists physical status I or II undergoing minor hand or forearm surgeries (duration of surgery 60 min or less, such as carpal tunnel release, ganglion excision, trigger finger, tendon or nerve repair, and fracture finger or metacarpal bone) .

Exclusion Criteria:

  • Patients with Raynaud's disease,
  • history of drug allergy, sickle cell anemia, Liver diseases and kidney diseases
  • Patients who had a history of allergy to the drugs used, recent or chronic use of analgesics,
  • uncontrolled hypertension, diabetic neuropathy, peripheral ischemia, , or any psychological disturbances

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): NCT03399474


Contacts
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Contact: Mohamed AH Makhlouf, residant 00201001795011 amakhloufsalama@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ghada M Aboelfadl, staff Assiut University

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Responsible Party: Ahmed Makhlouf, Clinical professor, Assiut University
ClinicalTrials.gov Identifier: NCT03399474    
Other Study ID Numbers: Assiut University Anathesia
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Makhlouf, Assiut University:
Regional Anesthesia, Dexmedetomidine and lidocaine
Additional relevant MeSH terms:
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Congenital Abnormalities
Acetaminophen
Diclofenac
Lidocaine
Dexmedetomidine
Nalbuphine
Anesthetics
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors