Clinical trial NCT02630290: Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial)
Official title: Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Plexus Block, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radius Fractures
Ulna Fractures
Hand Injuries
Wrist Injuries
Forearm Injuries
Keywords: Brachial plexus block
Dexmedetomidine
Ropivacaine
ultrasound-guided nerve block
supraclavicular brachial plexus block
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Duration of analgesia
timeFrame: up to 24 hours postoperatively
Secondary outcomes:
measure: Blood pressure (BP)
timeFrame: up to 24 hours postoperatively
measure: Heart rate (HR):
timeFrame: up to 24 hours postoperatively
measure: Peripheral oxygen saturation (SpO2)
timeFrame: up to 24 hours postoperatively
measure: Sensory block of median nerve
timeFrame: up to 30 minutes after administration of block
measure: Sensory block of ulnar nerve
timeFrame: up to 30 minutes after administration of block
measure: Sensory block of radial nerve
timeFrame: up to 30 minutes after administration of block
measure: Sensory block of musculocutaneous nerve
timeFrame: up to 30 minutes after administration of block
measure: Motor block of median nerve
timeFrame: up to 30 minutes after administration of block
measure: Motor block of ulnar nerve
timeFrame: up to 30 minutes after administration of block
measure: Motor block of radial nerve
timeFrame: up to 30 minutes after administration of block
measure: Motor block of musculocutaneous nerve
timeFrame: up to 30 minutes after administration of block
measure: Duration of motor block
timeFrame: up to 24 hours postoperatively
measure: Success rate of nerve block
timeFrame: 30 minutes after administration of block
measure: Postoperative analgesic requirement
timeFrame: up to 24 hours postoperatively
measure: Postoperative nausea and vomiting (PONV)
timeFrame: up to 24 hours postoperatively
measure: Abnormal sensation of brachial plexus
timeFrame: Day 1
Other outcomes:
measure: The block performance time
timeFrame: 1 day
measure: The number of block performance attempts
timeFrame: 1 day
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Xiangcai Ruan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu HH, Wang HT, Jin JJ, Cui GB, Zhou KC, Chen Y, Chen GZ, Dong YL, Wang W. Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014 Mar 26;9(3):e93114. doi: 10.1371/journal.pone.0093114. eCollection 2014.
citation: Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.
citation: Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
citation: Esmaoglu A, Yegenoglu F, Akin A, Turk CY. Dexmedetomidine added to levobupivacaine prolongs axillary brachial plexus block. Anesth Analg. 2010 Dec;111(6):1548-51. doi: 10.1213/ANE.0b013e3181fa3095. Epub 2010 Oct 1.
citation: Liu W, Guo J, Zheng J, Zheng B, Ruan X; Addition of Dexmedetomidine to Ropivacaine-Induced supraclavicular Block (ADRIB) investigator. Low-dose dexmedetomidine as a perineural adjuvant for postoperative analgesia: a randomized controlled trial. BMC Anesthesiol. 2022 Aug 5;22(1):249. doi: 10.1186/s12871-022-01791-6.