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 : Recruiting
First Posted : January 16, 2018
Last Update Posted : July 7, 2020
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: Lidocaine Hydrochloride 2% Drug: Dexmedetomidine 0.5 ug/kg Drug: Dexmedetomidine Injection 0.25 ug/kg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Analgesic Efficacy of Two Different Doses of Dexmedetomidine as Adjuncts to Lidocaine for Intravenous Regional Anesthesia: Randomized Clinical Trial.|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Active Comparator: Lidocaine only
Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline for intravenous regional anesthesia.
Drug: Lidocaine Hydrochloride 2%
Lidocaine Hydrochloride 2%
Experimental: 0.5 ug/kg dexmedetomidine
Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline (maximum dose200 mg)+ 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 of 20 ml/min for intravenous regional anesthesia.
Drug: Dexmedetomidine 0.5 ug/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)+ 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 of 20 ml/min. for intravenous regional anesthesia.
Drug: Dexmedetomidine Injection 0.25 ug/kg
- 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.
- 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).
- 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 .
- 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.
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
|Contact: Ghada M Abo Elfadl, MDemail@example.com|
|Ghada M Ab Elfadl||Recruiting|
|Assiut, Egypt, 71515|
|Contact: Ghada Abo Elfadl, MD firstname.lastname@example.org|