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

Primary Purpose

Limb Deformity

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine Hydrochloride 2%
Dexmedetomidine 0.5 ug/kg
Dexmedetomidine Injection 0.25 ug/kg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limb Deformity focused on measuring Regional Anesthesia, Dexmedetomidine and lidocaine

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghada M Ab Elfadl

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Lidocaine only

0.5 ug/kg dexmedetomidine

0.25 ug/kg dexmedetomidine

Arm Description

Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline for intravenous regional anesthesia.

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.

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.

Outcomes

Primary Outcome Measures

The time to first analgesic request.
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

Pain due to the tourniquet assessed with visual analogue scale (VAS) scores before and after the application of tourniquet and during the operation
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
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
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.

Full Information

First Posted
December 21, 2017
Last Updated
May 22, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03399474
Brief Title
Analgesic Efficacy of Two Doses of Dexmedetomidine as Adjuncts to Lidocaine for Intravenous Regional Anesthesia
Official Title
Comparison of Analgesic Efficacy of Two Different Doses of Dexmedetomidine as Adjuncts to Lidocaine for Intravenous Regional Anesthesia: Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed Description
Preoperative evaluation of the patients will be done including medical history, physical examination, and laboratory investigations. Patients should be in fasting state for at least 8 h before surgery, and the visual analog scale (VAS) (from 0 to 10: 0 = no pain up to 10 = severe pain) will be explained to the patients to express their pain. On arriving at the operating room, routine intraoperative monitors will be applied, such as a noninvasive blood pressure monitor, a five-lead ECG, and a pulse oximeter. Two (20 G) venous cannulae will be inserted, one in the dorsum of the operative hand and one in the other hand, for fluid infusion during surgery and for any intravenous medications. Patients will be premedicated with IV 0.05 mg/Kg of midazolam. After the patient is taken to the operating room, mean arterial blood pressure (MAP), peripheral oxygen saturation (SPO2) and heart rate (HR) will be monitored. The operative arm will be elevated for 2 minutes then exsanguinated with an esmarch bandage. A pneumatic double tourniquet will be placed a round upper arm, and the proximal cuff will be inflated to 250 mmHg. Circulatory isolation of the arm will be verified by inspection, absence of radial pulse, and loss of pulse oximetry tracing in the ipsilateral index finger. After the bandage is removed, 40 ml of the respective solutions will be injected over 20 seconds by an anesthesiologist. The Sensory block will be assessed by pinprick performed with a 22-gauge needle every 30 seconds until the dermatomal sensory block of medial and antebrachial cutaneous, ulnar, median and radial nerves achieved. Motor function will be assessed by asking the patients to flex and extend his/her wrist and fingers and complete motor block will be noted when no voluntary movement is possible. 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. After complete sensory and motor blocks is achieved, the distal tourniquet will be inflated to 250 mmHg, and the proximal tourniquet will be released and the surgery will be s started. MAP, HR and SPO2 level will be recorded before application of tourniquet and after the application of tourniquet every five minute and were measured after release of the tourniquet, and postoperatively at 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr and 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 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 . Both VAS and sedation levels will be recorded before and after the application of tourniquet and during the operation (10, 15, 20, 30, 40, 50 and 60 min). When pain due to tourniquet was > 3 on the VAS, patients will be given nalbuphine 5 mg intravenously increments up to 0.1 mg/kg and total administered dose will be noted. Oxygen will be administered with face mask if SPO2 is lower than 91%. At the end of the operation patients will be asked to qualify the operative conditions such as tourniquet pain or incisional pain. The tourniquet will be not deflated before 30 min and was not inflated more than 1.5 hours. At the end of the operation, the tourniquet deflation will be performed by cyclic deflation technique (the tourniquet was deflated three times in a cyclic manner with 10 seconds period of deflation). Sensory recovery time will be documented (time elapsed after tourniquet deflation up to recovery of pain in all innervated areas determined by pinprick test). Motor block recovery time will be noted (the time elapsed after tourniquet deflation up to movement of fingers). Also, first analgesic requirement time will be noted (the time elapsed after tourniquet release to the first patient request of analgesic). In the postoperative period 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. During the first 2 hours in the post-anesthetic care unit and later in the surgical ward, patients will be questioned for circumoral numbness and tingling, nausea and vomiting, skin rash, tinnitus, gastric discomfort and other side effects are noted if encountered and MAP, HR and VAS scores will be assed every 2 hours postoperatively during the first 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Deformity
Keywords
Regional Anesthesia, Dexmedetomidine and lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine only
Arm Type
Active Comparator
Arm Description
Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline for intravenous regional anesthesia.
Arm Title
0.5 ug/kg dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Arm Title
0.25 ug/kg dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride 2%
Intervention Description
Lidocaine Hydrochloride 2%
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.5 ug/kg
Intervention Description
pecedex
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injection 0.25 ug/kg
Intervention Description
pecedex
Primary Outcome Measure Information:
Title
The time to first analgesic request.
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain due to the tourniquet assessed with visual analogue scale (VAS) scores before and after the application of tourniquet and during the operation
Description
Pain due to the tourniquet will be ssessed with visual analogue scale (VAS) scores (0 = no pain and 10 = worst pain imaginable).
Time Frame
24 hours
Title
Levels of sedation assessed with the Ramsey sedation scale before and after the application of tourniquet and during the operation
Description
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 .
Time Frame
24 hours
Title
The onset, duration times of both sensory and motor blocks, Sensory block onset time, Motor block onset time
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ghada M Ab Elfadl
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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