Title SENSORY AND MOTOR BLOCK CHARACTERISTICS OF 0.75%ROPIVACAINE AND 0.5% LEVOBUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK: A RANDOMIZED COMPARATIVE STUDY
AIMAim of the study is to compare the block characteristics of equal volumes of levobupivacaine and ropivacaine in supraclavicular brachial plexus blocks for upper limb orthopaedic surgeries
OBJECTIVEPrimary Objective1. To Compare the onset of sensory and motor blockade. 2. To compare the duration of sensory and motor blockade. 3. To determine the postoperative analgesic effect of both drugs. 4. To assess the need of rescue analgesia in the postoperative period.
SECONDARY OBJECTIVE
To compare hemodynamic changes and adverse events
Study design
RANDOMISED DOUBLE BLINDED COMPARATIVE STUDY
Study CentreINSTITUTE OF ANAESTHESIOLOGY AND CRITICAL CARE, (ORTHOPAEDICS OT) Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai
Study population Patients scheduled for elective upper limb orthopaedic procedure
Inclusion criteria
• Patients aged between 18 and 60 years, both sexes • American Society of Anaesthesiologists Physical Status I or II • Patients who gave valid consent for the study
Exclusion Criteria • Patient refusal to participate or unable to give consent • History of allergy to local anaesthetics • Coagulation disorders • Infection at injection site • Patient with neurological deficits
Sample sizeTotal Sample Size: 102 (51 in each group)
Ethical clearance Obtained
Sampling technique Simple Random Sampling
Study procedure -Patients meeting the inclusion criteria during the pre-anaesthetic evaluation will be randomly assigned into 2 groups of 51 each by simple randomization method. -All patients included in the study will be premedicated with tablet alprazolam 0.5 mg and ranitidine 150 mg orally at night before surgery. On arrival of patients in the operating room, 18G intravenous cannula will be inserted on the non-operating hand and infusion of normal saline was started. The patients will be connected with monitor to record heart rate (HR), non-invasive measurement of blood pressure (BP), electrocardiogram (ECG) and oxygen saturation (SpO2) and baseline values recorded. One of the anaesthesiologist not involved in the monitoring of the patient will prepare the local anaesthetic study solutions. Patients and the observing anaesthesiologist will be blinded to the study drug used. -The Patients will be placed in supine position with the head turned away from the site of injection. The injection site will be infiltrated with 1 ml of lignocaine 2% subcutaneously. Brachial plexus is located by using ultrasound. -After standard skin preparation, under ultrasound guidance Supraclavicular brachial plexus will be blocked with 20 ml 0.75% Ropivacaine in patients randomised under group A and with 20 ml of 0.5% levobupivacaine in patients randomised under group B -During injection, negative aspiration will be performed after every 5ml to avoid intravascular injection. -Sensory blockade will be checked by ice packs every minute till 10 minutes and every 5 minutes till 30 minutes and post-operatively. Onset of sensory blockade was defined as loss of cold sensation. Onset time is the time taken from the completion of drug injection to loss of sensation in any of the C5 to T1 dermatomes. - Duration of sensory blockade was defined as the time between onset of sensory block and return of dull pain and VAS < 4. This was assessed every 30minutes postoperatively in at least three major nerve distributions. -Motor block at the shoulder was assessed by asking the patient to elevate the arm while keeping the elbow straight (superior trunk function) and at the hand was assessed by grip strength and thumb movement (middle and inferior trunk function). Onset of motor blockade was defined as the time required from completion of drug injection to complete loss of motor power. - Duration of motor blockade was defined as the time between onset of motor block and regained ability of the patient to move fingers. -Haemodynamic parameters were recorded at 0, 5, 10, 15, 20, 25, 30, 45 mins, 1st hr. thereafter every 15mins till completion of surgery and thereafter every second hourly till 12 hrs. -Total duration of analgesia was defined as the time between onset of analgesia and onset of pain (VAS >4) and the time when patients received the first dose of rescue analgesic. -For statistical analysis, complete failure and unsatisfactory block was considered as failures and was excluded from the study. -Postoperative pain was assessed using the visual analogue scale (VAS) [0-no pain, 2-mild pain, 5-moderate pain, 8-severe pain, 10-unbearable pain].) every hour till the block lasted. -Time for first dose of rescue analgesic in post-operative period and total rescue analgesic requirement in 12 hrs were recorded. - The end-point of the study was time from performance of the block to the onset of pain as determined by VAS score of 4 or more and also the time when full power returned to the forearm and hand. - Patients were monitored for any signs of cardiovascular or central nervous system toxicity (changes in BP, heart rate, rhythm, signs or symptoms of CNS stimulation), hypersensitivity reaction for the drug and any evidence of pneumothorax and will also be monitored and followed-up for 24hrs.
Analysis plan - Analysis will be carried out by mean and standard deviation for quantitative variables, frequency and proportion for categorical variables. - Data will also be represented using appropriate diagrams like bar diagram, pie diagrams. - All Quantitative variables will be checked for normal distribution by using visual inspection of histograms and normality Q-Q plots. - Shapiro wilk test will also be conducted to assess normal distribution. Shapiro wilk test p value of >0.05 will be considered as normal distribution. - Quantitative parameters mean values will be compared between study groups using independent t test if normally distributed and Mann Whitney test if not normally distributed. - For testing the influence of the demographic factors on the study parameters Chi Square Test will be used. -P value < 0.05 will be considered statistically significant. -IBM SPSS version 24.0 will be used for statistical analysis.
PROFORMA
NAME AGE SEX IP NO DATE WEIGHT HEIGHT GROUP: A / B DIAGNOSIS
SURGICAL PROCEDURE
COEXISTING ILLNESS
EXAMINATION
GENERAL EXAMINATION PALLOR / ICTERIC / CYANOSIS / CLUBBING / LYMPHADENOPATHY / PEDEL EDEMA PR BP SPO2 CVS RS ABDOMEN CNS
ANESTHESIA DETAILS
AIRWAY
ASSESSMENT: ASA I/ASA II
PARAMETERS OBSERVED
TIME IN MINS 0 5 10 15 20 25 30 45 60 120 240 360 480 600 720 HR NIBP SPO2 RESCUE ANALGESIA ADVERSE EVENTS
PARAMETERS GROUP A GROUP B ONSET OF SENSORY BLOCKADE ONSET OF MOTOR BLOCAKDE DURATION OF SENSORY BLOCK DURATION OF MOTOR BLOCK TOTAL DOSE OF RESCUE ANALGESIA REQUIRED HEMODYNAMICS ADVERSE EVENTS
INFORMATION TO PARTICIPANTS
Investigator : Dr. HIBA AJMAL
Name of the Participant: Age: Sex: IP no:
Title: Sensory and Motor Blockade Characteristics of 0.75%Ropivacaine and 0.5%Levobupivacaine in Supraclavicular Brachial Plexus Block: A Randomized Comparative Study
You are invited to take part in this research study. We have got approval from the IEC. You are asked to participate because you satisfy the eligibility criteria. We want to compare block characteristic between two drugs 0.7%Ropivacaine vs 0.5% Levobupivacaine in Supraclavicular Brachial Plexus block in Upper limb orthopaedics procedure.
What is the Purpose of the Research?
• Compare the onset of sensory and motor blockade, duration of blockade, requirement of rescue analgesia • Hemodynamic changes and any adverse events.
All the patients in the study will be divided into two groups. Group A: will receive 20 ml of 0.75% ropivacaine Group B: will receive 20 ml of 0.5% Levobupivacaine
If you don’t want to participate, you can withdraw from the study and your safety is our prime concern.
Time: Signature / Thumb Impression of Patient Date: Place: Chennai Patient Name:
Signature of the Investigator:
Name of the Investigator: DR. HIBA AJMAL PATIENT CONSENT FORM
Study title: Sensory and Motor Blockade Characteristics of 0.75%Ropivacaine and 0.5%Levobupivacaine in Supraclavicular Brachial Plexus Block: A Randomized Comparative Study
Study Centre:
Institute of Anesthesiology and Critical care, (ORTHOPAEDICS OT), Madras Medical College, Chennai
Participant name: Age: Sex: I.P. No
I confirm that I have understood the purpose of procedure for the above study. I have the opportunity to ask the question and all my questions and doubts have been answered to my satisfaction.
I have been explained about the study. I have been explained about the safety, advantage and disadvantage of the tests.
I understand that my participation in the study is voluntary and that I am free to withdraw at anytime without giving any reason.
I understand that investigator, regulatory authorities and the ethics committee will not need my permission to look at my health records both in respect to current study and any further research that may be conducted in relation to it, even if I withdraw from the study. I understand that my identity will not be revealed in any information released to third parties or published, unless as required under the law. I agree not to restrict the use of any data or results that arise from the study.
Time:
Date: Signature / thumb impression of patient
Place: Chennai. Patient name:
Signature of the investigator: Name of the investigator: Dr. HIBA AJMAL
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