CTRI Number |
CTRI/2021/09/036773 [Registered on: 23/09/2021] Trial Registered Prospectively |
Last Modified On: |
21/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
COMPARISON OF TWO LOCAL ANAESTHETIC DRUGS (ROPIVACAINE AND LEVOBUPIVACAINE) FOR NERVE BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERY |
Scientific Title of Study
|
COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE
FOR ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN
ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Karthiga Manoharan |
Designation |
Post Graduate |
Affiliation |
ABVIMS AND DR.RML HOSPITAL |
Address |
Department of Anaesthesia
ABVIMS and DR.RML Hospital,
New Delhi
New Delhi DELHI 110001 India |
Phone |
9677556650 |
Fax |
|
Email |
karthiga96.mano@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR VINOD BALA DHIR |
Designation |
PROFESSOR |
Affiliation |
ABVIMS AND DR.RML HOSPITAL |
Address |
Department of Anaesthesia
ABVIMS and DR.RML Hospital,
New Delhi
New Delhi DELHI 110001 India |
Phone |
9868223931 |
Fax |
|
Email |
drvinoddhir@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Karthiga Manoharan |
Designation |
Post Graduate |
Affiliation |
ABVIMS AND DR.RML HOSPITAL |
Address |
Department of Anaesthesia
ABVIMS and DR.RML Hospital,
New Delhi
New Delhi DELHI 110001 India |
Phone |
9677556650 |
Fax |
|
Email |
karthiga96.mano@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology
A.B.V.I.M.S AND DR.RML HOSPITAL |
|
Primary Sponsor
|
Name |
ABVIMS AND DRRML HOSPITAL |
Address |
Doctors hostel,
DR.RML Hospital,
New Delhi |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
ABVIMS AND DRRML HOSPITAL |
DR.RML Hospital,
New Delhi |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR KARTHIGA |
A.B.V.I.M.S AND DR.RML HOSPITAL |
Department of Anaesthesia
ABVIMS and DR.RML Hospital,
New Delhi New Delhi DELHI |
9677556650
karthiga96.mano@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ABVIMS AND DR.RML HOSPITAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE |
COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE FOR ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY
Group 1 – Patients will receive 30 ml of 0.5% ropivacaine with 25 µg Fentanyl
Group 2 – Patients will receive 30 ml of 0.5% levobupivacaine with 25 µg Fentanyl
Observations
1. Onset of Sensory and motor block
2. Duration of Sensory and motor block will be assessed every hour till the recovery
3. Heart rate, SBP, DBP, MAP, SpO2 will be recorded every 5 mins for the first 15 mins and thereafter every 15 mins throughout the surgery
|
Intervention |
ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY |
COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE FOR ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY
SUPRA-CLAVICULAR BRACHIAL PLEXUS BLOCK
Position: This block will be performed with the patient in the supine position, with the patient’s head turned away from the side to be blocked.
USG guided Technique:
After sterile preparation and draping, the transducer is positioned in the transverse plane immediately proximal to the clavicle, slightly posterior to at its midpoint. The transducer is tilted caudally, as if to image the chest contents, to obtain a cross-sectional view of the subclavian artery. The brachial plexus is seen as a collection of hypoechoic oval structures posterior and superficial to the artery. Colour Doppler should be routinely used prior to needle insertion to rule out the passage of large vessels (i.e., dorsal scapular artery, transverse cervical artery, suprascapular artery) in the anticipated trajectory of the needle.
Using a 25-gauge needle, 1–2 mL of local anesthetic is injected into the skin 1 cm lateral to the transducer to decrease discomfort during needle insertion. The block needle is then inserted in plane toward the brachial plexus, in a lateral-to-medial direction. After careful aspiration, 1–2 mL of normal saline is injected to confirm proper needle placement. When the injection displaces the brachial plexus away from the needle, an additional advancement of the needle 1–2 mm closer to the plexus may be required to accomplish adequate local anesthetic spread.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Age 18-65 years
2. ASA Grade I & II
3. Patients scheduled for upper limb orthopedic surgeries |
|
ExclusionCriteria |
Details |
1. Patients with infection at the site of injection.
2. Patients with known history of allergy to any of the study medications .
3. Patients with bleeding disorders and those on anti-coagulant therapy.
4. Patients with neurological disorders and neuropathy.
5. Failure of block (in these patients, general anaesthesia will be supplemented). |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study the duration of sensory and motor blockade of ropivacaine and levobupivacaine in
Ultrasound guided supra-clavicular brachial plexus block for upper limb surgeries. |
Time of giving supraclavicular brachial plexus block is taken as baseline (0 minutes). Patient is monitored every 15 mins in the intraoperative period followed by every 1 hour in the postoperative period upto 24 hours. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the hemodynamic profile (HR, SBP, DBP, MAP, SPO2) in both the groups |
HR, SBP, DBP, MAP, SPO2 will be monitored every 2 hours for the first 6 hours and thereafter
every 4 hours till the need for rescue analgesia.
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
30/09/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
AIM:
To compare the duration of sensory and motor blockade with Ropivacaine and Levobupivacaine in
Ultrasound guided Supraclavicular brachial plexus block for upper limb surgeries.
PRIMARY OBJECTIVE:
To study the duration of sensory and motor blockade of ropivacaine and levobupivacaine in
Ultrasound guided supra-clavicular brachial plexus block for upper limb surgeries.
SECONDARY OBJECTIVE:
To study the hemodynamic profile (HR, SBP, DBP, MAP, SPO2) in both the groups.
METHODOLOGY After a detailed pre-anaesthetic check-up, an informed consent will be obtained from all the patients
after explaining the details of the procedure. In the operation theatre, pre-operative parameters
including heart rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean
Arterial Pressure (MAP) and oxygen saturation (SpO2) will be recorded and an intravenous access
established and iv fluids started. Patients will be sedated with intravenous Midazolam 0.03 mg/kg,
supra-clavicular brachial plexus block will then be performed .
SUPRA-CLAVICULAR BRACHIAL PLEXUS BLOCK
Position: This block will be performed with the patient in the supine position, with the patient’s head
turned away from the side to be blocked.
USG guided Technique:
After sterile preparation and draping, the transducer is positioned in the transverse plane immediately
proximal to the clavicle, slightly posterior to at its midpoint. The transducer is tilted caudally, as if to
image the chest contents, to obtain a cross-sectional view of the subclavian artery. The brachial plexus
is seen as a collection of hypoechoic oval structures posterior and superficial to the artery. Colour
Doppler should be routinely used prior to needle insertion to rule out the passage of large vessels (i.e., dorsal scapular artery, transverse cervical artery, suprascapular artery) in the anticipated trajectory of
the needle.
Using a 25-gauge needle, 1–2 mL of local anesthetic is injected into the skin 1 cm lateral to the
transducer to decrease discomfort during needle insertion. The block needle is then inserted in plane
toward the brachial plexus, in a lateral-to-medial direction. After careful aspiration, 1–2 mL of normal
saline is injected to confirm proper needle placement. When the injection displaces the brachial plexus
away from the needle, an additional advancement of the needle 1–2 mm closer to the plexus may be
required to accomplish adequate local anesthetic spread.
After proper needle placement: Group 1 – Patients will receive 30 ml of 0.5% ropivacaine with 25 µg Fentanyl (n=21) Group 2 – Patients will receive 30 ml of 0.5% levobupivacaine with 25 µg Fentanyl (n=21)
Surgical anaesthesia will be achieved when the patient shows complete loss of sensation in the surgical
field with the concomitant inability to elevate the operated limb.
OBSERVATION:
The following observations will be made: • Time of onset of sensory block : the time from the completion of the injection of drug till the
patient can no longer feel the cold sensation in the surgical field by the Ice test method. • Time of onset of motor block : the time from the completion of the injection of drug till the
complete block i.e. Modified Bromage scale of 3. • ECG and SpO2 will be monitored continuously throughout the surgery. • HR, SBP, DBP, MAP will be recorded every 5 mins for the first 15 mins and thereafter every
15 mins throughout the surgery. • Duration of sensory and motor blockade will be assessed every hour till the recovery. • Duration of sensory block will be defined as time from the loss of temperature sensation till
the recovery of sensation (by Ice test method). • Duration of motor blockade will be defined as the time when Modified Bromage scale of 3 is
achieved till the time of achievement of Modified Bromage scale of 2. • HR, SBP, DBP, MAP, SPO2 will be monitored every 2 hours for the first 6 hours and thereafter
every 4 hours till the need for rescue analgesia. • After the recovery of sensations, pain will be assessed using Visual Analogue Scale (VAS
score 0= no pain to 10=worst pain) every hour till the need for rescue analgesia. Rescue
analgesia will be administered at a VAS of ≥4. |