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

NCT02630290 | Completed Phase 4 DMC

• 1 other identifier: GZZD-2015008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Blood pressure (BP)

  up to 24 hours postoperatively

• Heart rate (HR):

  up to 24 hours postoperatively

• Peripheral oxygen saturation (SpO2)

  up to 24 hours postoperatively

• Sensory block of median nerve

  up to 30 minutes after administration of block

• Sensory block of ulnar nerve

  up to 30 minutes after administration of block

Other Outcomes (2)

• The block performance time

  1 day

• The number of block performance attempts

  1 day

Study Arms (2)

Ropivacaine

PLACEBO COMPARATOR

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

Ropivacaine + Dexmedetomidine

EXPERIMENTAL

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

Interventions

Ropivacaine DRUG

Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine

Also known as: placebo

Ropivacaine

Ropivacaine + Dexmedetomidine DRUG

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

Also known as: experimental

Ropivacaine + Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 020, China

Location

Related Publications (5)

• 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.

  PMID: 24671181 RESULT

• 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.

  PMID: 23161360 RESULT

• 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.

  PMID: 23587874 RESULT

• 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.

  PMID: 20889939 RESULT

• 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.

  PMID: 35931989 DERIVED

MeSH Terms

Conditions

Radius Fractures; Ulna Fractures; Hand Injuries; Wrist Injuries; Forearm Injuries

Interventions

Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiangcai Ruan, MD, PhD

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept Pain, Principle Investigator, Professor

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 15, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

CN (1)