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

August 10, 2016 updated by: Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 24 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 24 hours postoperatively
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.
up to 24 hours postoperatively
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.
up to 24 hours postoperatively
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 30 minutes after administration of block
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.
up to 24 hours postoperatively
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
30 minutes after administration of block
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.
up to 24 hours postoperatively
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).
up to 24 hours postoperatively
Abnormal sensation of brachial plexus
Time Frame: Day 1
Patient's self-reported abnormal sensation of the hand and forearm.
Day 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The block performance time
Time Frame: 1 day
Time elapses from probe positioning to the end of local anesthetic injection.
1 day
The number of block performance attempts
Time Frame: 1 day
Number of block performance attempts
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou First People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiangcai Ruan, MD, PhD, Guangzhou First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GZZD-2015008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings