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

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

Study Overview

• Status: Completed
• Conditions: Wrist Injuries; Radius Fractures; Forearm Injuries; Hand Injuries; Ulna Fractures
• Intervention / Treatment: Drug: Ropivacaine; Drug: Ropivacaine + Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 020
      • Guangzhou First Municipal People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	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.	up to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (BP)	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.	up to 24 hours postoperatively
Heart rate (HR):	HR, bradycardia (HR < 50 beats/min), and tachycardia (HR > 100 beats/min) will be recorded at the same time as BP recording.	up to 24 hours postoperatively
Peripheral oxygen saturation (SpO2)	SpO2 and hypoxemia (SpO2 <90%) will be recorded at the same time as BP recording.	up to 24 hours postoperatively
Sensory block of median 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 median nerve locations.	up to 30 minutes after administration of block
Sensory block of ulnar nerve	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.	up to 30 minutes after administration of block
Sensory block of radial nerve	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.	up to 30 minutes after administration of block
Sensory block of musculocutaneous nerve	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.	up to 30 minutes after administration of block
Motor block of median nerve	Motor block of median nerve is defined by thumb and fifth finger pinch.	up to 30 minutes after administration of block
Motor block of ulnar nerve	Motor block of ulnar nerve is defined thumb and second finger pinch.	up to 30 minutes after administration of block
Motor block of radial nerve	Motor block of radial nerve is defined by finger abduction.	up to 30 minutes after administration of block
Motor block of musculocutaneous nerve	Motor block of musculocutaneous nerve is defined by flexion of the elbow.	up to 30 minutes after administration of block
Duration of motor block	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.	up to 24 hours postoperatively
Success rate of nerve block	A successful block is defined as surgery without patient discomfort and the need for supplementation of local infiltration or general anesthesia	30 minutes after administration of block
Postoperative analgesic requirement	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.	up to 24 hours postoperatively
Postoperative nausea and vomiting (PONV)	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).	up to 24 hours postoperatively
Abnormal sensation of brachial plexus	Patient's self-reported abnormal sensation of the hand and forearm.	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The block performance time	Time elapses from probe positioning to the end of local anesthetic injection.	1 day
The number of block performance attempts	Number of block performance attempts	1 day

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital
• Investigators: Principal Investigator: Xiangcai Ruan, MD, PhD, Guangzhou First People's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Ropivacaine; ultrasound-guided nerve block; Brachial plexus block; supraclavicular brachial plexus block
• Additional Relevant MeSH Terms: Arm Injuries; Wounds and Injuries; Fractures, Bone; Wrist Injuries; Radius Fractures; Hand Injuries; Forearm Injuries; Ulna Fractures; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Ropivacaine
• Other Study ID Numbers: GZZD-2015008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided