Comparison of Efficacy of Bupivacaine in Supraclavicular Block With or Without Dexmedetomidine
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery.
      Patients were randomly allocated using sealed opaque envelope bearing A- (Injection
      bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL
      plus dexmedetomidine I ug/kg diluted to 2 ml).

      Supraclavicular block under ultrasound and nerve stimulator guidance was performed.
    

Detailed description: 
      This study was conducted after approval of the institutional ethical review committee and
      then from College of Physicians and Surgeons Pakistan. Patients with end stage renal disease
      (ESRD) coming for Brachial vein transposition surgery, and fulfilling the inclusion criteria
      were enrolled in this study. All patients were instructed not to consume solid food after
      midnight prior to surgery. A brief history of demographic data was taken from each patient.
      Each participant's height in meters was measured using wall mounted scale, weight in kg using
      a weighing machine, and BMI kg/m² was noted prior to operation. The findings of quantitative
      variables (age, height, weight, sensory blockade, motor blockade and qualitative variables
      (gender, diabetes mellitus type II, hypertension, and dyslipidemia) were entered in the
      proforma attached as an annexure. Patients were randomly allocated using sealed opaque
      envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and
      B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Only the
      anaesthesiologists for the specific case were aware of the treatment allocation until the end
      of the surgical procedure. The investigator for assessing the block and the other outcome
      variables, remained blinded to the patient's group allocation.

      Routine monitoring of heart rate & rhythm by ECG, and arterial blood pressure using
      non-invasive blood pressure (NIBP) including systolic, diastolic & mean arterial blood
      pressure, and peripheral oxygen saturation (SPO2) using a pulse oximeter was performed on
      each patient. The supraclavicular brachial plexus block was performed under the supervision
      of a consultant anaesthesiologist in a supine position with a head up to 45 degrees. An
      Intravenous (IV) line was established and the skin was disinfected and a linear probe, high
      frequency 12 MHz was placed firmly over the supraclavicular fossa, the probe was positioned
      in the transverse plane immediately superior to the clavicle at approximately its midpoint.
      The probe was tilted caudally to obtain a cross sectional view of the subclavian artery. The
      brachial plexus was seen as a collection of hypo-echoic oval structures lateral and
      superficial to the artery. Using a 25 gauge needle 1 to 2 ml of 2% lidocaine was locally
      infiltrated into the skin 1 cm lateral to the probe to decrease the discomfort during needle
      insertion. A 50 mm or 80 mm length, short bevel, insulated nerve stimulator needle was used.
      Peripheral nerve stimulation (PNS) is an additional way of confirming nerve location. Initial
      settings was set at 0.5 mA current, 2 Hz frequency, and pulse width of 0.1 milliseconds.
      Close approximation to the divisions of brachial plexus was confirmed by getting nerve
      stimulation on 0.3 mA current. The needle was advanced along the long axis in the same plane
      as the ultrasound beam. The shaft and tip was visualized in real time as the needle was
      advanced towards the target nerves. The drug in either group was injected under direct vision
      of ultrasound beams and by confirming with nerve stimulation. Sensory blockade and motor
      blockade was assessed every 3 minutes. Time of onset of sensory and motor blockade and
      duration of sensory and motor blockade were noted as per operational definition.
      Postoperative pain was assessed with visual analogue scale (VAS). Patients were asked to mark
      a point on the line that matches the intensity of pain on the Visual Analogue Score hourly
      for 4 hours post operatively. Those patients having arm pain equal to or greater than 4 on
      VAS, were given rescue analgesic (inj. Paracetamol (15mg/kg 1/V) and duration of analgesia
      were noted as per operational definition.
    

Intervention name(s): DEXmedetomidine; saline
Intervention type(s): Drug; Other
Intervention description(s): 28 mL of Bupivacain 0.25% was mixed with Dexmedetomidine 1 microgram/kg body weight mixed in 2 mL = total volume 30 mL; 28 mL of Bupivacain 0.25% was mixed with 2 mL of Normal saline = total volume 30 mL
Other intervention name(s): DEX
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment