Plain English Summary
Background and study aims
Axillary brachial plexus block is a regional anesthestic technique that is sometimes used as an alternative or in addition to general anesthetic for surgery on the arm or hand. The aim of this study is to investigate the effects of adding the pain medication dexmedetomidine to local anaesthetic levobupivacaine in axillary brachial plexus block.
Who can participate?
Patients aged 18-60 scheduled for forearm and hand surgery under axillary block
What does the study involve?
Participants are randomly allocated into two groups: one group are treated with levobupivacaine and the other group are treated with levobupivacaine and dexmedetomidine. Demographical data, blood pressure, heart rate, oxygen levels, sensory and motor block onset times and block durations, time to first painkiller use, total painkiller need and side effects are recorded for each patient.
What are the possible benefits and risks of participating?
It is hoped that dexmedetomidine will prolong the duration of anesthesia and pain relief with a shorter onset time.
Where is the study run from?
Cumhuriyet University (Turkey)
When is the study starting and how long is it expected to run for?
November 2011 to February 2012
Who is funding the study?
Investigator initiated and funded (Turkey)
Who is the main contact?
Dr Kenan Kaygusuz
kaygusuzkenan@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kenan Kaygusuz
ORCID ID
Contact details
Cumhuriyet University School of Medicine
Department of Anesthesiology
Sivas
58140
Turkey
-
kaygusuzkenan@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of dexmedetomidine addition to levobupivacaine in axillary brachial plexus blockade
Acronym
Study hypothesis
In this study the aim is to investigate the effects of dexmedetomidine addition to levobupivacaine in axillary brachial plexus block. It is hypothesized that dexmedetomidine addition will prolong the duration of anesthesia and analgesia with a shorter onset time.
Ethics approval
Cumhuriyet University Ethics Committee, 04/04/2007, ref: 2007-4/4
Study design
Randomized controlled double-blind prospective trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Anaesthesia and analgesia in the arm
Intervention
The patients were randomly divided into two groups:
Group L (n=32): Levobupivacaine (Chirocaine, 5 mg/mL; Abbott Lab/Turkey) with isotonic sodium chloride
Group D (n=32): Levobupivacaine and dexmedetomidine (Precedex 200 mcg / 2 mL, Meditera, Turkey) with isotonic sodium chloride
The randomization was achieved by random number table. The drug solutions were prepared by an anesthesiologist who was not involved in the study.
The patients were monitored for their mean arterial blood pressures (MAP), heart rate (HR), and peripheral oxygen saturation (SpO2) in the operation room before the blockage and baseline values were recorded. All patients were not given any premedications. After insertion of a 20-gauge intravenous (IV) catheter in a peripheral vein in the contralateral arm, axillary block was performed with the patient in the supine position and the upper arm with 90° abduction and the elbow with 110° flexion. During the application, a nerve stimulator (Stimuplex, Braun, Germany) was used for the nerve localization. For blockage, 22G, 50 mm stimulating needle (Stimuplex D, B.Braun Melsungen AG, Japan) was used. The stimulator was adjusted to 1.0 mA, 2 Hz, 0.1 ms parameters at the beginning of the procedure. The location of the needle was accepted adequate when an output current < 0.5 mA caused a slight distal motor response. After the localization of radial, ulnar, median and musculocutaneous nerves, group L (n=32) patients were given a total 40 mL solution of 39 mL levobupivacaine 0.5% with 1 mL of isotonic sodium chloride solution, and group D (n=32) patients were given a total 40mL solution of 39 mL levobupivacaine 0.5% with 1 mL volume of 1 µg kg-1 dexmedetomidine plus isotonic sodium chloride solution in a double-blind mode. A multi-stimulation technique was used in all of the patients of both groups. Anesthetic mixture (10 mL for each nerve = 40 mL) were injected after identifying the radial, ulnar, median and musculocutaneous nerves in each patient. During injection, negative aspiration was performed every 3.04.0 ml to avoid intravascular injection. If there was any blockade failure in a nerve distribution region, even if the block was adequate for the surgery, the patients were excluded from the study. All axillary brachial plexus blocks were performed by the same anesthesiologist.
Sensory and motor blockades of median, radial, ulnar, and musculocutaneous nerves, and HR, MAP, SpO2 values were recorded after 5, 10, 20, 30, 60, 80 min from the blockade and 10, 30 min, 1, 2, 4, 6, 12 hours after the end of the surgery. Sensory blockade of each nerve was assessed by pinprick test. Sensory blockade was rated by the patient on a verbal analog scale from 100 (normal sensation) to 0 (no sensation). Motor block was evaluated by thumb adduction (ulnar nerve), thumb abduction (radial nerve), flexion of the elbow and pronation of forearm (musculocutaneous), and thumb opposition (median nerve). Motor block evaluation were performed using a modification of the Levvott rating scale from 6 (normal muscular force) to 0 (complete paralysis).
The onset time of the sensory and motor blockades was defined as the time between the end of the local anesthetic injection and no response to the pinprick test and complete paralysis. The duration of sensory block was considered as the time interval between the complete sensory block and the first postoperative pain, and the duration of motor block was defined as the time interval between the complete paralysis and complete recovery of motor function. Time to first analgesic use and total need for analgesics were recorded during postoperative first 12 hours. Postoperative pain levels were evaluated by a 10 cm visual analog scale (VAS) from 0 (no pain) to 10 (severe pain). Hypotension (a 20% decrease from the baseline value), bradycardia (HR < 50 beats per minute), hypoxemia (SpO2 < 90%), nausea and vomiting occurrences were also recorded. If there were hypotension, bradycardia and hypoxemia, it was planned to administrate ephedrine 10 mg IV, atropine 1mg IV and 4-5 l h-1 O2 inhalation therapy respectively. If VAS values were above 4 the patient was given intramuscular (IM) diclofenac 75 mg. The anesthesiologist who evaluated the blockade responses and the patients were blinded as to the solution used.
Intervention type
Drug
Phase
Not Applicable
Drug names
Dexmedetomidine, levobupivacaine
Primary outcome measure
1. Sensory and motor block onset time, defined as the time between the end of the local anesthetic injection and no response to the pinprick test and complete paralysis
2. Sensory and motor block durations. The duration of sensory block was considered as the time interval between the complete sensory block and the first postoperative pain, and the duration of motor block was defined as the time interval between the complete paralysis and complete recovery of motor function
3. Time to first analgesic use recorded during postoperative first 12 hours
Secondary outcome measures
1. Mean arterial pressure
2. Heart rate
Overall trial start date
20/11/2011
Overall trial end date
28/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18-60
2. Male and female participants
3. Scheduled forearm and hand surgery patients
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant exclusion criteria
1. Patients with a history of cardiac, respiratory, hepatic, or renal failure, coagulopathy, and allergy to amid local anesthetics
2. Receiving adrenoreceptor agonist or antagonist therapy, chronic analgesic therapy
3. Pregnant women
Recruitment start date
20/11/2011
Recruitment end date
28/02/2012
Locations
Countries of recruitment
Turkey
Trial participating centre
Cumhuriyet University
Sivas
58140
Turkey
Sponsor information
Organisation
Cumhuriyet University (Turkey)
Sponsor details
School of Medicine Research Hospital
Sivas
58140
Turkey
-
cevdetduger@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list