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Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial) (ADRIB)

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ClinicalTrials.gov Identifier: NCT02630290
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Radius Fractures Ulna Fractures Hand Injuries Wrist Injuries Forearm Injuries Drug: Ropivacaine Drug: Ropivacaine + Dexmedetomidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Plexus Block, a Randomized Controlled Study
Study Start Date : December 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Ropivacaine
After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle tip repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under continuous ultrasound monitoring.
Drug: Ropivacaine
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine
Other Name: placebo

Experimental: Ropivacaine + Dexmedetomidine
After skin infiltration with 1-2 mL of lidocaine 2%, a 21-gauge 90-mm spinal needle will be inserted into the brachial plexus sheath using in-plane technique. After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine plus 30 microg dexmedetomidine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under realtime ultrasound monitoring.
Drug: Ropivacaine + Dexmedetomidine
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine
Other Name: experimental




Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: up to 24 hours postoperatively ]
    Postoperative pain using visual analog scale (VAS, 0-100, 0 = no pain, 100 = maximum imaginable pain) will be assessed. Duration of analgesia is defined by time between administration of block and the postoperative pain >3.


Secondary Outcome Measures :
  1. Blood pressure (BP) [ Time Frame: up to 24 hours postoperatively ]
    Noninvasive arterial BP is measured at the non-operated arm. episode of hypotension (30% decrease in mean BP in relation to baseline values) and hypertension (30% increase in mean BP in relation to baseline values) will be recorded.

  2. Heart rate (HR): [ Time Frame: up to 24 hours postoperatively ]
    HR, bradycardia (HR < 50 beats/min), and tachycardia (HR > 100 beats/min) will be recorded at the same time as BP recording.

  3. Peripheral oxygen saturation (SpO2) [ Time Frame: up to 24 hours postoperatively ]
    SpO2 and hypoxemia (SpO2 <90%) will be recorded at the same time as BP recording.

  4. Sensory block of median nerve [ Time Frame: up to 30 minutes after administration of block ]
    is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the median nerve locations.

  5. Sensory block of ulnar nerve [ Time Frame: up to 30 minutes after administration of block ]
    Sensory block of ulnar nerve is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the ulnar nerve locations.

  6. Sensory block of radial nerve [ Time Frame: up to 30 minutes after administration of block ]
    Sensory block of radial nerve is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the radial nerve locations.

  7. Sensory block of musculocutaneous nerve [ Time Frame: up to 30 minutes after administration of block ]
    Sensory block of musculocutaneous nerve is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the musculocutaneous nerve locations.

  8. Motor block of median nerve [ Time Frame: up to 30 minutes after administration of block ]
    Motor block of median nerve is defined by thumb and fifth finger pinch.

  9. Motor block of ulnar nerve [ Time Frame: up to 30 minutes after administration of block ]
    Motor block of ulnar nerve is defined thumb and second finger pinch.

  10. Motor block of radial nerve [ Time Frame: up to 30 minutes after administration of block ]
    Motor block of radial nerve is defined by finger abduction.

  11. Motor block of musculocutaneous nerve [ Time Frame: up to 30 minutes after administration of block ]
    Motor block of musculocutaneous nerve is defined by flexion of the elbow.

  12. Duration of motor block [ Time Frame: up to 24 hours postoperatively ]
    Duration of motor block is defined as the time interval between the administration of the block and the recovery of complete motor function of the hand and forearm assessed.

  13. Success rate of nerve block [ Time Frame: 30 minutes after administration of block ]
    A successful block is defined as surgery without patient discomfort and the need for supplementation of local infiltration or general anesthesia

  14. Postoperative analgesic requirement [ Time Frame: up to 24 hours postoperatively ]
    IV tramadol 50mg will be administered when postoperative pain >3, and be titrated up by 50 mg increments as needed for pain every 4 to 6 hours, with the maximum total dose of 250mg.

  15. Postoperative nausea and vomiting (PONV) [ Time Frame: up to 24 hours postoperatively ]
    The incidence of PONV will be recorded using a 4-point objective score (1 = no PONV;2 = mild nausea, no vomiting; 3 = excessive nausea or vomiting;4 = vomiting ≥2 times).

  16. Abnormal sensation of brachial plexus [ Time Frame: Day 1 ]
    Patient's self-reported abnormal sensation of the hand and forearm.


Other Outcome Measures:
  1. The block performance time [ Time Frame: 1 day ]
    Time elapses from probe positioning to the end of local anesthetic injection.

  2. The number of block performance attempts [ Time Frame: 1 day ]
    Number of block performance attempts



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery: elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block
  • American Society of Anesthesiologist(ASA) physical status of Ⅰ to III
  • Age between 18 to 60 years old

Exclusion Criteria:

  • Having an ongoing another clinical trials
  • Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
  • Peripheral neuropathy
  • Cerebrovascular disease
  • Psychiatric disease
  • Coagulopathies
  • Pregnant women
  • Liver and kidney dysfunction
  • Heart failure
  • Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
  • Patient refusal

Information from the National Library of Medicine

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): NCT02630290


Locations
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China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 020
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Xiangcai Ruan, MD, PhD Guangzhou First People's Hospital

Publications of Results:
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Responsible Party: Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Director of Dept Pain, Principle Investigator, Professor, Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT02630290    
Other Study ID Numbers: GZZD-2015008
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital:
Brachial plexus block
Dexmedetomidine
Ropivacaine
ultrasound-guided nerve block
supraclavicular brachial plexus block
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Hand Injuries
Wrist Injuries
Forearm Injuries
Ulna Fractures
Wounds and Injuries
Arm Injuries
Dexmedetomidine
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics