Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial)
Condition: Radius Fractures; Ulna Fractures; Hand Injuries; Wrist Injuries; Forearm Injuries
MeSH terms: Wounds and Injuries; Fractures, Bone; Radius Fractures; Hand Injuries; Wrist Injuries; Forearm Injuries; Ulna Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent
      influences on the filed of perineural block. It could shorten the onset time and prolong the
      duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced
      bradycardia or hypotension has recently attracted considerable attention because of
      potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A
      low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few
      studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural
      adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine
      added to ropivacaine would safely enhance the duration of analgesia without adverse effects
      when compared with ropivacaine alone. Investigators will conduct a single-center,
      prospective, randomized, triple-blind, controlled trial in patients undergoing elective
      forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using
      either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is
      self-reported duration of analgesia . Secondary outcomes include onset time and duration of
      motor and sensory block, total postoperative analgesics, and safety assessment (adverse
      effects and postoperative abnormal sensation).
    

Detailed description: 
      Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent
      influences on the filed of perineural block. It could shorten the onset time and prolong the
      duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced
      bradycardia or hypotension has recently attracted considerable attention because of
      potentially grave consequences, including sinus arrest and refractory cardiogenic shock.
      Although meta-analysis showed that perineural dexmedetomidine as a local anaesthetic adjuvant
      for neuraxial and peripheral nerve blocks produced reversible bradycardia in only 7% of
      brachial plexus block patients and no effect on the incidence of hypotension, various
      clinical studies reported a significant decrease in heart rate. A low dose may help minimize
      cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the
      clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was
      designed to test the hypothesis that low-dose dexmedetomidine, which till today has not been
      reported in the literature, added to ropivacaine for brachial plexus block would safely
      enhance the duration of analgesia without adverse effects when compared with ropivacaine
      alone. Investigators will conduct a single-center, prospective, randomized, triple-blind,
      controlled trial in patients undergoing elective forearm and hand surgery under
      ultrasound-guided supraclavicular brachial plexus block using either 20 mL of 0.5%
      ropivacaine or 0.5% ropivacaine plus 30 microg dexmedetomidine. The primary outcome is
      self-reported duration of analgesia . Secondary outcomes include onset time and duration of
      motor and sensory block, total postoperative analgesics, and safety assessment (adverse
      effects including cardiovascular inhibitions and postoperative abnormal sensation). Data will
      be collected and analyzed in a blinded fashion.
    

Intervention name(s): Ropivacaine; Ropivacaine + Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine; Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine
Other intervention name(s): placebo; experimental
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial plexus block; Dexmedetomidine; Ropivacaine; ultrasound-guided nerve block; supraclavicular brachial plexus block