Ketamine Versus Dexmedetomidine in Supraclavicular Brachial Plexus Block
Condition: Supraclavicular Brachial Plexus Block
Study type: Interventional

Summary: 
      Intervention model description: The patients were randomly classified into three groups using
      computer-generated table numbers each contain (25) patients.

      Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg
      ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal
      saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml
      0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description:
      The investigator's study is a prospective, randomized, double-blind
    

Detailed description: 
      This randomized, prospective, double-blind study was carried out on 75 ASA Physical Status
      I-II adults aged 18-75 years old scheduled to undergo elective and emergency forearm and hand
      surgeries under ultrasound-guided supraclavicular brachial plexus block. After obtaining the
      local ethics committee of El-Minia university hospital approval and written informed consent
      was taken of the patient, this study was conducted from April 2019 to February 2020 in
      El-Minia university hospital. The investigators excluded any patient with bleeding disorders,
      damage or disease of the brachial plexus, uncontrolled diabetes mellitus, and patients with
      neuromuscular diseases, Patients with a local skin infection at the site of injection or
      patients with known hypersensitivity to studied drugs.

      Preoperative assessment and preparation: A careful assessment of medical history, general
      examination including chest, heart, abdomen, site of injection and other systems were carried
      out. Routine investigations were done as complete blood picture, ECG (electrocardiogram)
      renal and liver functions. An explanation of the visual analog scale was done to each
      patient.

      Preparation of the studied medications: The patients were randomly classified into three
      groups using computer-generated table numbers each contains (25) patients. Ketamine group
      (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine,
      Dexmedetomidine group (group D) 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus
      1µg\kg dexmedetomidine (precedex® Hospira,Inc., Lake Forest USA).

      Control group (group C) 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. All medications
      were prepared in similar sterile coated bottles by the supervisor who didn't include in the
      anesthetic or operative team, 75 bottles numbered from 1 to 75 were prepared. After
      completion of the study, the key was opened by the supervisor Block technique: On patient's
      arrival to the operating room, a 20 G intravenous cannula was inserted in a peripheral vein
      of unaffected limb and standard monitoring commenced as noninvasive blood pressure (NIBP),
      (ECG), and Oxygen saturation (Spo2) (UltraviewSL2700, Spacelaps, USA), all equipment and
      drugs for general anesthesia and resuscitation were prepared, the ultrasound device
      (Sonosite, Nanomax, USA ) lubricating gel, 21guge 50 mm length, short bevel, insulated
      stimulating needle (Laboratoires pharmaceutiques, Vygon, France). Patient lie supine with the
      head turned to the other side and ipsilateral arm adducted gently with a flexed elbow. Under
      the complete aseptic condition, the identified area and the ultrasound probe was prepared
      with anti-septic (Povidone-Iodine 10%) solution and the skin infiltrated with 1-2 ml of
      lidocaine 2% solution subcutaneously, the brachial plexus was visualized by placing the
      transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the
      clavicle. Two distinct appearances of the supraclavicular brachial plexus was seen, it either
      appeared as a grape-like cluster of 5 to 6 hypoechoic circles, located lateral and superior
      to the subclavian artery between the anterior and middle scalene muscles at the lower
      cervical region or as 3 hypoechoic circles with hyperechoic outer rings, the predetermined
      volume of 40 mL of the study drug solution was administered around the brachial plexus after
      negative aspiration to avoid accidental intravascular injection, expansion of the brachial
      plexus sheath was considered as an indication of correct needle placement, multiple
      injections were used to deposit the total amount of the study drugs, skin massage for about 3
      minutes was done to facilitate drug distribution.

      Parameters assessed:

        -  Hemodynamic data: The hemodynamic variables as HR, MAP and Spo2 were assessed. The
           parameters were recorded preoperatively just before the block as a baseline value, at
           5,10,20,30,60, 90 minutes during the operative time and at 1,2,4,6,9 and 12 hours after
           the end of the operation.

        -  Sensory block was assessed by pinprick test using a 3-point scale [16] Grade 0 = normal
           sensation, Grade 1 = loss of sensation of pinprick (analgesia), and Grade 2 = loss of
           sensation of touch (anesthesia).

        -  Motor block was determined by thumb abduction (radial nerve), thumb adduction (ulnar
           nerve), thumb opposition (median nerve), and flexion of elbow (musculocutaneous nerve)
           according to the modified Bromage 3 point scale: Grade 0: Normal motor function with
           full flexion and extension of elbow, wrist, and fingers. Grade 1: Decreased motor
           strength with the ability to move the fingers only. Grade 2: Complete motor block with
           an inability to move the fingers [16].

        -  Onset time for sensory and motor block: the time interval between the end of local
           anesthetic administration and complete sensory and motor block by min.

        -  Sensory block duration: the time interval between the complete sensory block and
           complete resolution of anesthesia on all the nerves (score 0(

        -  Motor block duration: the time interval from complete motor block to complete recovery
           of motor function of hand and forearm (grade 0) by hours.

        -  Visual analog scale (VAS): postoperative, the patients were familiarized with a 10-point
           visual analog scale (VAS) ranged from 0 = no pain, up to 10 = the worse imaginable pain.
           VAS was measured at 1, 2, 3, 6, 9, 12 hours. When it equals or >4 the investigators give
           IM diclofenac sodium (75 mg amp) (Voltaren, Novartis Pharmaceuticals Corporation,
           Switzerland).

        -  Time of first analgesic request: The time passed from supraclavicular brachial plexus
           block to the patient's first request for analgesic medication by hours

        -  Total analgesic requirements in 24 hours) diclofenac consumption)

        -  Sedation score: was assessed according to the modified Ramsay Sedation Scale 1987(RSS)
           from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented,
           tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or
           loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response
           [17].

        -  Adverse effects: any adverse effects such as hypotension (i.e. 20% decrease relative to
           baseline), bradycardia (HR <60 beats/min), nausea, vomiting, hypoxemia (SpO2 <90%),
           local hematoma, hemothorax, pneumothorax, recurrent laryngeal nerve block, intravascular
           injection, Horner's syndrome and signs of local anesthetic toxicity were recorded during
           the operation and for 12 hours postoperative.
    

Intervention name(s): Supraclavicular Brachial Plexus Block with bupivacaine; Supraclavicular Brachial Plexus Block with Ketamine; Supraclavicular Brachial Plexus Block with Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block; drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block; drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
Other intervention name(s): C group; K group; D group
Intervention MeSH terms: Dexmedetomidine; Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment