| CTRI Number |
CTRI/2021/09/036445 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Volume of 0.5% ropivacaine needed to produce anaesthesia of upper limb in 50% of patients using ultrasound guided multiple injection lateral sagittal infraclavicular plexsus block |
|
Scientific Title of Study
|
Median effective volume of 0.5% ropivacaine for ultrasound guided multiple injection lateral sagittal infraclavicular plexus block: a dose finding study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeetinder Kaur Makkar |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia
PGIMER, Chandigarh
Sector 12 , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009510 |
| Fax |
|
| Email |
jeet1516@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeetinder Kaur Makkar |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia
PGIMER, Chandigarh
Sector 12 , Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009510 |
| Fax |
|
| Email |
jeet1516@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeetinder Kaur Makkar |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia
PGIMER, Chandigarh
Sector 12 , Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009510 |
| Fax |
|
| Email |
jeet1516@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate institute of Medical Education & Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education Research |
| Address |
Sector 12, Chandigarh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jeetinder kaur Makkar |
Post Graduate institute for Medical Education and Research |
Department of Anaesthesia, Trauma OT Complex, 3rd floor, Advanced trauma centre, PGIMER, Sector 12
Sector 12 ,
Chandigarh
CHANDIGARH |
7087009510
jeet1516@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infraclavicular brachial plexus block |
The patients will be placed supine with the arm to be blocked abducted. We will use a high-frequency (5–12 MHz) ultrasound probe (Sonosite, Inc. Bothell. WA 9802 USA). Transducer will be positioned in the parasagittal plane in the lateral infraclavicular space to identify the axillary artery. Once the artery is identified, we will identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery. 18G 10mm stimuplex needle will be inserted in-plane from the cephalad end of the probe, with the insertion point just inferior to the clavicle. The needle position will be refined until stimulation is achieved at a current of ∼0.5 mA. Needle insertion and injection will be considered intraneural if nerve stimulation at a current of 0.2 mA (0.1 ms) or less results in an evoked motor response or if a high resistance (pressure) to injection or nerve swelling was noticed upon initiating the injection. In these instances, the injection will be immediately stopped, and patients with suspected intraneural injections will be excluded from analyses. Operator’s objective will be to selectively surround each sonographically imaged brachial plexus cord with predetermined volume of local anaesthetic; however, if a cord could not be imaged, local anaesthetic placement will be done on an arbitrary basis according to an imaginary clock face in the following sequential order: posterior cord at 6 o’clock, lateral cord at 8 o’clock, and medial cord at 2 o’clock (in the triangular anterior space between axillary artery and vein). The needle bevel will be faced dorsally for each of the 3 positions; however, when manipulation will be performed close to the artery, the bevel will be directed away from the artery. Following this, a 20-gauge catheter will be inserted through the needle and advanced 1- 2 cms beyond the needle tip, to be localised dorsolateral to the posterior cord of brachial plexus. The needle will be then withdrawn over the catheter. All catheters will be tunnelled under the skin and the site will be covered with clear occlusive dressing |
| Comparator Agent |
Not applicable |
Not applicable |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Society of Anesthesiologists (ASA) physical status I-II patients, in the age group of 18-60 years, with a body mass index (BMI) between 18 and 30 kg.m-2, scheduled to undergo forearm and hand surgeries will be assessed for eligibility |
|
| ExclusionCriteria |
| Details |
Patients with local infection at the block site, coagulopathy, sepsis, BMI>30, allergy to local anesthetics, uncontrolled hypertension or ischemic heart disease, renal or hepatic dysfunction, pre-existing neurological deficits, prior surgery in the infraclavicular fossa, psychiatric illness, patients who failed to understand the scoring systems used in the study and patients who refused to give consent for the study will be excluded. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective will be to estimate MEV90 for multiple-injection US-guided ICB. Volume assignment will be carried out using a biased coin design (BCD) up-and-down sequential method (UDM), where the volume administered to each patient will depend upon the response of previous patient. First subject will receive 21 ml based upon a previous study MEV50 of 19 ml in patients receiving ultrasound-guided LSIB with ropivacaine 7.5 mg/ml. based on the response of the previous patient. In case of failure, the next subject will receive a higher volume (0.5ml/ cord). If the previous patient had a successful block, the next subject will be randomized to a lower volume |
30 minutes after performance of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to requirement of first bolus, mean pain scores at various time intervals |
Baseline ie on shifting to PACU, 2hrs, 4hrs , 8hrs, 12hrs, 24hrs |
|
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Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Relatively large volumes of local
anaesthetic (LA) and/or multiple injections are used to produce successful BPB.
The minimum effective volume of LA needed for producing a multiple injection
LICF brachial plexus block is not known. Knowledge
of minimum effective volume is very important, so as to reduce the risk of
systemic toxicity without affecting the efficacy of block. In a dose finding
study done for single injection technique, the MEV in 95% of patients for an
ultrasound-guided LSIB with ropivacaine 7.5 mg/ml was estimated to be 31 ml
(95% CI, 18–45 ml). Technique involved injection of drug in periarterial sector
from 3 to 11 o’clock and within 2cm of axis of axillary artery. We will inject selectively
surround each sonographically imaged brachial plexus cord and define the local anesthetic required for multiple
injection technique
|