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TRANSCRIPT
TO ESTIMATE THE MINIMUM EFFECTIVE VOLUME OF LIGNOCAINE-BUPIVACAINE
MIXTURE FOR ULTRASOUND GUIDED MULTIPOINT SUBFASCIAL
SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK
DR.GOBINATH JREG. NO: 1601021002 | MAY/2016 OF ADMISSION | MAY/2019OF
EXAMINATION
MD(ANAESTHESIOLOGY),MGMCRI
GUIDEDR. SRIPRIYA. R
ASSOCIATE PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY, MGMCRI
Co-GUIDEDR.CHARULATHA .R
ASSISTANT PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY, MGMCRI
Co-GUIDE
DR. SIVASHANMUGAM.TPROFESSOR & HEAD
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH
INSTITUTE
CANDIDATE
Candidate Name : GOBINATH
Course of Study : MD ANAESTHESIOLOGY
University Identity No : 1601021002
Mobile Phone No : +918098023218
E-mail Address : [email protected]
Month/Yr of Admission : MAY 2016
Month/Yr of Examination : MAY 2019
GUIDES
GUIDE: DR. SRIPRIYA.R
Associate Professor
Anesthesiology
9365815939
CO GUIDE: DR.CHARULATHA
Assistant Professor
Anesthesiology
9894909652
2
CO GUIDE: DR.SIVASHANMUGAM
Professor
Department of Anaesthesiology
9442505567
PART II – THE PROTOCOL
1 INTRODUCTION
“Regional anaesthesia always works-provided you put the right dose of the right drug in the right place.” (1) When blocks were performed under landmark guidance the LA dosage was calculated principally based on the maximal allowable dose, as the deposition of the drugs in close proximity to the nerve was not very precise. By using USG guidance, the right place can now be clearly identified. With better understanding of anatomy of the supraclavicular brachial plexus, the right place of injection of LA in this area has constantly been changing. It is now understood that the brachial plexus in the supraclavicular area is arranged in several clusters & hence Multipoint Subfascial injection of LA can provide consistent blockade of the four nerves supplying the upper limb. [Musculocutaneous nerve, Median nerve, Ulnar nerve and Radial nerve] (2)
When using LA to provide surgical anesthesia , we need to provide
1. Dense blockade
2. The duration of block should be such that it covers the entire duration of surgery and also provides adequate pain relief during the immediate post –operative period.
Our previous experience with supraclavicular brachial plexus block, has shown that lignocaine- bupivacaine combination can satisfy these two requirements.
The previous study by Tran etal, (3)
have reported that 23 ml of the drug combination is the MEV required to produce block in 50 % of patients and MEV 95 is 42 ml.
We are however able to produce block in all patients by using 20 ml of the drug combination.
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2 AIMS AND OBJECTIVES
Aim : To determine the minimum effective volume of lignocaine- bupivacaine
mixture in producing conduction blockade at 30 minutes.
Primary outcome –volume of mixture that can produce a successful block at 30
minutes.
Secondary outcome- 1. Duration of block
2. Measurement of cross sectional area of brachial plexus.
3 REVIEW OF LITERATURE
Edel Duggan et al have determined the Minimum Effective Volume of Local Anesthetic ( 2% lignocaine with adrenaline and 0.5 % bupivacaine equal mixture) for Ultrasound-Guided Supraclavicular Brachial Plexus Block. Twenty-one adults undergoing elective upper limb surgery received a US-guided supraclavicular block. The minimum effective anesthetic volume in 50% of patients was determined using the Dixon and Massey up-and-down method. The initial volume of local anesthetic injected was 30 mL, which was subsequently varied by 5 mL for each consecutive patient according to the response in the previous patient. The effective volume in 95% of patients (ED95) was calculated using probit transformation and logistic regression. The minimum effective anesthetic volume in 50% and calculated effective volume in 95% of patients were 23 mL ( 13 -39 mL) and 42 mL (19-65 mL) respectively.They concluded that the calculated volume of LA required for US-guided supraclavicular block does not seem to differ from the conventionally recommended volume required for supraclavicular blocks using non US-based nerve localization techniques.
Sivashanmugam et al 2015 compared two different techniques of injecting local anaesthetic drugs under ultrasound guidance for supraclavicular Brachial Plexus Block.They performed a randomised comparative study in 32 patients undergoing upper extremity surgery. A 1:1 mixture of local anaesthetics (2%lignocaine with adrenaline and 0.5%bupivacaine) 25 ml was injected subfascially or extrafascially to the brachial plexus sheath. They assessed the Block Onset time and duration of post operative analgesia.Their study concluded that subfascial injection provided faster onset (7 +3)min than extrafascial (20 + 10 ) min and longer duration of analgesia subfascial (9.3 + 1.4 ) and extra fascial (6.1 + 1.4)hours.
Jae Gyok Song et al have determined the minimum effective volume of mepivacaine
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for ultrasound-guided supraclavicular block. Thirty patients undergoing forearm and hand surgery received ultrasound-guided supraclavicular block with 1.5% mepivacaine. The initial volume of local anesthetic injected was 24 ml, and local anesthetic volume for the next patient was determined by the response of the previous patient. The next patient received a 3 ml higher volume in the case of the failure of the previous case. If the previous block was successful, the next volume was 3 ml lower. MEV was estimated by the Dixon and Massey up and down method. MEV in 95, 90, and 50% of patients (MEV95, MEV90, and MEV50) were calculated using probit transformation and logistic regression. MEV95 of 1.5% mepivacaine was 17 ml ( 13-42 ml), MEV90 was 15 ml ( 12-34 ml), and MEV50 was 9 ml ( 4-12 ml).
JADRANKA PAVIČIĆ ŠARIĆ et al have studied the effects of age on onset time and duration of sensory blockade in ultrasound guided supraclavicular block. Middle-aged (n = 22) and elderly (n = 22) patients undergoing upper limb surgery received an ultrasound-guided supraclavicular brachial plexus block. The starting volume was 30 ml (50 : 50 mixture, 0.5% levobupivacaine, 2% lidocaine). The minimum effective local anesthetic volume in middle-aged and elderly was 23.0 ml (13.7–32.3) vs. 11.9 ml (9.3–14.6). The difference was statistically significant [ P = 0.027]. They concluded that elderly patients need a reduced minimum effective anaesthetic volume for ultrasound-guided supraclavicular block. Additionally they observed a smaller cross-sectional surface area of brachial plexus in the supraclavicular region in elderly compared to adults.
4 RESEARCH QUESTION OR HYPOTHESIS
By using USG guidance the volume of LA that is required for successful block can
be decreased.
5 SUBJECTS AND METHODS
5.1 STUDY SUBJECTS
The Study Involves HUMANS
5.2 TYPE OF STUDY
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Interventional trial
5.3 PLACE OF STUDY
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE ,
MAHATHMA GANDHI MEDICAL COLLEGE AND RESEARCH CENTRE
5.4 SELECTION PROCESS
5.4.1 STUDY POPULATION
Patients with forearm fractures posted for surgery
5.4.2 VOLUNTEERS RECRUITEMENT PROCESS
NA
5.4.3 INCLUSION CRITERIA
ASA 1/2.
Male patients
20 -40 yrs with forearm fracture.
5.4.4 EXCLUSION CRITERIA
• 1) Patient refusal for the block
• 2) History of bleeding disorders
• 3) Local infection at the site of block
• 4) Pre-existing neurological deficit
• 5) Respiratory compromise.
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• 6) Known allergy to local anaesthetic drug.
• 7) Patients in whom the supraclavicular sono-anatomy is not clear.
5.4.5 SAMPLING PROCEDURE
Sequential Allocation
5.4.6 STUDY GROUPS
The Number of Groups is: 1
5.4.7 SAMPLE SIZE
NA
5.5 METHODOLOGY / PROCEDURES:
TECHNIQUE
After getting approval from the Hospital ethics committee, patients undergoing
surgeries for forearm bone fractures and fulfilling inclusion and exclusion criteria
will be recruited in the study. All the blocks will be performed in the procedure room
under standard monitoring (electrocardiography, pulse oximetry and non-invasive
blood pressure). An 18-gauge IV line will be secured. An IV sedation of 2mg
midazolam will be given before the ultrasound procedure. The patient will be
positioned with the arms by the side. Blocks will be performed under ultrasound
guidance by using high frequency linear probe. The brachial plexus will be scanned
close to the subclavian artery as a bunch of grapes. The cross sectional area of the
brachial plexus will be measured. The plexus will be approached by a 23G spinal
needle connected to a PMO line and drug taken in a 20ml syringe (DISPOVAN). The
study drug will be injected subfascial at 4 different points. Adequate spread of local
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anesthetics will be confirmed by USG imaging. Final removal of needle after
injection of drug will be taken as block time.
Sensory Blockade will be assessed on a three point Qualitative Scale for perception
of sensation to Ether soaked cotton.
0 - perceives both touch and cold temperature
1 - perceives only the touch but not the temperature
2 - perceives neither touch nor temperature
Sensory Blockade will be assessed in the territories of Musculocutaneous nerve
(MCN) - Lateral forearm , Median Nerve (MN) – Tip of Middle Finger , Ulnar Nerve
(UN) – Little Finger and Radial Nerve (RN) – Anatomical snuff box.
Motor Blockade will be assessed on a 3 point Qualitative Scale.
0 - Normal Motor Function ( Power 4/5 , 5/5 )
1 - Decreased Motor Function ( Power 3/5 , 2/5 )
2 - No Motor Power (Power 0/5 , 1/5 )
for the Four Terminal Branches(Elbow Flexion - Musculocutaneous Nerve , Thumb
Opposition - Median Nerve , Thumb Adduction - Ulnar Nerve , Thumb Abduction-
Radial Nerve).
Successful block is defined as a composite score of 14/16 with a sensory block of
7/8 at 30 minutes of block. The observer who records the sensory and motor
parameters will be blinded to the volume of LA used.
Dixon and massey’s up and down methodology will be followed to determine the
minimum effective volume in 50% of patients. The first patient will receive a block
volume of 20 ml of 2%lignocaine with adrenaline and 0.5% bupivacaine 50:50
mixture. The volume for the subsequent patient will be determined by success or
failure of the block. The drug volume will be increased by 5 ml in case of block
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failure and decreased by 5ml in case of block success. This will be continued till 3
consecutive up and downs are observed. After three consecutive up and downs are
observed, the drug volume will be altered by 2.5 ml and study continued till three
consecutive up- downs are observed. The mid point of the down to up values will be
taken as minimum effective volume in 50 % of individuals.
Block failures will be managed by performing rescue blocks distally depending on
the nerve areas spared.
Postoperatively, Patient will be instructed to inform when they experience pain.
Time of first occurrence of pain post operatively will be noted. Block time to
perception of pain will be taken as duration of analgesia. The study will end when
the patient complaints of pain. 1 gm Acetaminophen IV will be given when the
patient complains of pain.
5.5.1 INTERVENTIONS/DRUGS USED
Inj lignocaine with adrenaline 2%, bupivacaine 0.5%.
23 G spinal needle
Route- supraclavicular brachial plexus.
LA sensitivity testing will be done on the day before surgery.
5.5.2 PROCUREMENT OF INVESTIGATIONAL DRUGS,
STORAGE, DISPENSING, ETC.
Click to replace with Text
5.6 STUDY TERMINATION
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Study will be terminated when three consecutive down to up sequences are observed
with a drug volume difference of 2.5 ml.
6 STUDY VARIABLES
1.
S. No Name of the dependent / independent variables
Scale of measurement (Quantitative / qualitative)
Descriptive / Inferential Statistics to be used
1 Volume of LA used Quanitative Mean volume2 Duration of analgesia Quantitative Mean3 Cross sectional Area of
the brachial plexusQuantitative Mean
6.1 DATA COLLECTION
Data will be collected using predefined data capture form. Secondary Data will be
collected from hospital records. Privacy and Confidentiality will be maintained. All
patient identifiable numbers and information will be stripped and replaced by
anonymous numbers.
6.2 STATISTICAL METHODS
The mid point of the down to up values will be taken as minimum effective volume
in 50 % of individuals.
MEV 95 will be calculated by probit transformation and logistic regression analysis.
7 REFERENCES
1. Denny NM, Harrop-Griffiths W. Location, location, location! Ultrasound imaging in regional anaesthesia. British Journal of Anaesthesia 2005; 94: 1–3
2. Sivashanmugam, T., Suja Ray, M. Ravishankar, V. Jaya, E. Selvam, and Manoj Kumar Karmakar. “Randomized Comparison of Extrafascial Versus Subfascial Injection of Local Anesthetic During Ultrasound-Guided Supraclavicular Brachial Plexus Block.” Regional Anesthesia and Pain Medicine,2015;4:337–43.
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3. Edel Duggan, Hossam El Beheiry, Anahi Perlas, Mario Lupu, Alina Nuica, Vincent W.S. Chan, and Richard Brull. Minimum Effective Volume of Local Anesthetic for Ultrasound-Guided Supraclavicular Brachial Plexus Block. Reg Anesth Pain Med 2009;34: 215-218
4. Jae Gyok Song, Dae Geun Jeon, Bong Jin Kang, and Kee Keun Park. Minimum effective volume of mepivacaine for ultrasound-guided supraclavicular block. Korean J Anesthesiol 2013 July 65(1): 37-41
8 PRELIMINARY WORK DONE ALREADY
NA
9 ETHICAL ISSUES
This study involves humans and requires frequent testing of sensory and motor
blockade. Only temperature and light touch is used for sensory assessment and
avoids pinprick or crude touch.
10 INFORMED CONSENT PROCEDURE
NAME OF THE RESEARCH PROJECT:
“TO ESTIMATE THE MINIMAL EFFECTIVE VOLUME OF
LIGNOCAINE-BUPIVACAINE MIXTURE FOR ULTRASOUND
GUIDED MULTIPOINT SUBFASCIAL SUPRACLAVICULAR
BRACHIAL PLEXUS BLOCK” We welcome you and thank you for having
accepted our request to consider whether you can participate in our study. This sheet
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contains the details of the study. The possible risks discomfort and benefits to the
participants are also given.
You can read and understand by yourself; if you wish, we are ready to read and
explain the same to you.
If you do not understand anything or if you want any more details we are ready to provide the same.
1. What is the purpose of the study?
The purpose of this study is to estimate minimal effective volume of LA
mixture in onset and duration of analgesia in ultrasound guided
supraclavicular brachial plexus block,so that it provides better analgesia for
the patients.
2. Who / where this study is being conducted?
This study is being conducted by Dr.Gobinath. Post Graduate
medical student belonging to anaesthesiology department under supervision
of Dr. Sripriya ( Associate Professor) & Dr.Charulatha (Assistant Professor) .
3. Why am I being considered as one of the participant?
Based on indications for upper limb surgery
5. Should I definitely take part in this study?
No. The choice is yours. If you do not wish to participate, you will not be
included in this study; even then you would continue to receive the medical treatment
without any prejudice.
5. If I am participating in this study, what would be my responsibilities?
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After understanding the details of the study, you should give us written consent. You
have to permit us to utilise your clinical data and co-operation during procedure.
6. Are there any benefits for me / public?
Yes. We can use a lower volume of LA to produce the block.
7. Will there be any discomfort / risks to me?
Yes. Failure rate and risk of complications(pneumothorax
/haemothorax,arterial puncture) which will be taken care with utmost vigilance.
8. Will I be paid for the study?
No. You will not be paid.
9. Will my participating in this study, my personal details will be kept
confidentially?
Yes, confidentiality will be maintained.
10. Will I be informed of this study’s results and findings?
Yes, if you want you can get the details from us.
11. Can I withdraw from this study at any time during the study period?
Yes. You can withdraw at any time during the study period.
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11 QUALITY CONTROL
Please give Quality Control and Assurance Procedures if applicable
Name of Officer designated by the department for quality control:
DR.SIVASHANMUGAM (Head of the Department )
Designation:HEAD OF DEPARTMENT
Telephone No: 9442505567
E-mail:[email protected]
12 SPONSORSHIPS
a. Sponsors for the study, if any (with address, contact number and email)
b. Outside funding, if any
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13 INVESTIGATORS DECLARATION
This is to certify that the protocol entitled “TO ESTIMATE THE MINIMAL
EFFECTIVE VOLUME OF LIGNOCAINE-BUPIVACAINE MIXTURE
FOR ULTRASOUND GUIDED MULTIPOINT SUBFASCIAL
SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK” was reviewed by us
for submission to the SBV Institutional Ethics Committee and certified that this
protocol represents an accurate and complete description of the proposed research.
We have read the ICMR guidelines, ICP-GCP guidelines/CPCSEA guidelines/and
other applicable guidelines and undertake to ensure that the rights and welfare of the
study subjects are protected.
The study will be performed as per the approved protocol only. If any deviation is
warranted, the same will be presented to the ethical committee and permission will
be sought. We assure that the study will be terminated immediately in case of any
unforeseen adverse consequences and we will inform the same to the ethical
committee immediately.
Dr. SRIPRIYA RAssociate professorDept.of AnaesthesiologyGuide DD/MM/YYYY
Dr. CHARULATHAAssistant Professor Dept.of AnaesthesiologyCo-guide DD/MM/YYYY
Dr. GOBINATHDepartment of AnaesthesiologyCANDIDATE/PI DD/MM/YYYY
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Dr. SIVASHANMUGAMHead of Department of Anaesthesiology with Dept. Seal DD/MM/YYYY
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