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NCT Number: NCT02630290

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

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).

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Key information

Conditions

Radius Fractures Arm Injuries Forearm Injuries Fractures, Bone Hand Injuries Ulna Fractures Wounds and Injuries Wrist Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine

Other names: placebo

Ropivacaine + Dexmedetomidine

Drug

Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine

Other names: experimental

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Guangzhou First People's Hospital

Other

Registry information

Official study title

Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Plexus Block, a Randomized Controlled Study

Acronym: ADRIB

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2015
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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