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

Hand Injuries Clinical Trial

— ADRIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630290
• Other study ID #: GZZD-2015008
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2015
• Last updated: August 10, 2016
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Guangzhou First Municipal People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Surgery: elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block

• American Society of Anesthesiologist(ASA) physical status of ? 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 a2 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ropivacaine
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine
• Ropivacaine + Dexmedetomidine
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine

Locations

Country	Name	City	State
China	Guangzhou First Municipal People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First Municipal People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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/jour — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The block performance time	Time elapses from probe positioning to the end of local anesthetic injection.	1 day	No
Other	The number of block performance attempts	Number of block performance attempts	1 day	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Peripheral oxygen saturation (SpO2)	SpO2 and hypoxemia (SpO2 <90%) will be recorded at the same time as BP recording.	up to 24 hours postoperatively	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Motor block of radial nerve	Motor block of radial nerve is defined by finger abduction.	up to 30 minutes after administration of block	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	Abnormal sensation of brachial plexus	Patient's self-reported abnormal sensation of the hand and forearm.	Day 1	Yes