| CTRI Number |
CTRI/2022/03/041352 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
23/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of success rate of USG guided supraclavicular block by single-point versus multiple-point injection technique |
|
Scientific Title of Study
|
A prospective randomised interventional study for success of USG guided supraclavicular block by single-point versus multiple-point Injection technique at SMS medical college, Jaipur during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Mangal |
| Designation |
Senior professor |
| Affiliation |
Sawai Mansingh Medical College, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Mangal |
| Designation |
Senior professor |
| Affiliation |
Sawai Mansingh Medical College, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Meena |
| Designation |
PG student |
| Affiliation |
Sawai Mansingh Medical College, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
8209731172 |
| Fax |
|
| Email |
Shekhar1992@icloud.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College, Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Dept. of Anaesthesiology, Second Floor, Dhanvantri OPD BLock, SMS Hospital, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Vandana Mangal |
Sawai Mansingh Medical College and Hospital |
Department of Anesthesiology, Second floor, Dhanwantri Building,SMS Hospital, JLN Marg, Jaipur
Jaipur
RAJASTHAN |
9829056816
vandanamangal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A: 102 patients will receive USG guided supraclavicular block using single point injection technique with 15 ml of 0.5% Ropivacaine. |
1. Time required to complete the procedure in each group will be recorded
2. Patients will be evaluated for onset of sensory and motor block every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic . Sensory blockade will be assessed by Pin Prick and Cold Test. Motor block will be assessed by asking the patient to move elbow, wrist and fingers.
3. Sparing of nerves will be noted and supplemented. The onset times of sensory and motor block will be noted. |
| Intervention |
GROUP B: 102 patients will receive USG guided supraclavicular block using multiple point injection technique with 15 ml of 0.5% Ropivacaine. |
1. Time required to complete the procedure in each group will be recorded
2. Patients will be evaluated for onset of sensory and motor block every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic . Sensory blockade will be assessed by Pin Prick and Cold Test. Motor block will be assessed by asking the patient to move elbow, wrist and fingers.
3. Sparing of nerves will be noted and supplemented. The onset times of sensory and motor block will be noted.
|
| Comparator Agent |
USG guided supraclavicular block
Single point versus multiple point injection technique |
Comparison in terms of success rate (i.e nerve sparing) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing surgical procedure on upper limb of duration 1-4 hours.
2. Patients of either gender of Age group of 18 to 60 year.
3. ASA grade I -III.
4. BMI OF 18-30 kg/m2. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Patients not willing to participate in study and uncooperative patients. 2. Coagulopathies, any neuropathy.
3. Allergy to LA (Ropivacaine)
4. Local pathology at the injection site
5. Disability limiting the performance of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in proportion of success rate (i.e., nerve sparing) and mean of time taken to perform procedures |
1. Evaluation of nerves assessment by every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic .
2. Time taken to perform procedures in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean onset of sensory and motor block |
Evaluation of nerves assessment by every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic . |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
01/04/2022 |
| 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="0"
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
|
Patient satisfying inclusion criteria will be selected and taken in OT
Patient identity will be confirmed, PAC will be done and informed written consent will be checked.
Noninvasive monitors (NIBP,Pulse oximeter,ECG) will be monitored and ringer lactate will be started intravenously
Patient will lie in supine position, with the head turned to the opposite side. Under all aseptic precautions, ultrasound guided supraclavicular brachial plexus block will be performed after explaining the procedure in each group. Using sonosite micromaxx high frequency linear probe Group A (n=102) USG guided singlepoint injection supraclavicularblock given by injecting 15ml of 0.5% Ropivacaine
Group B(n=102) USG guided multiple point injection supraclavicular block given by injecting 15ml 0.5% Ropivacaine
Here, time required to complete the procedure in each group will be recorded
Patients will be evaluated for onset of sensory and motor block every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic . Sensory blockade will be assessed by Pin Prick and Cold Test. Motor block will be assessed by asking the patient to move elbow, wrist and fingers. Sparing of nerves will be noted and supplemented. The onset times of sensory and motor block will be noted.
Once the patient will achieve sensory block of grade 2 then surgeons will be asked to proceed. Injection Midazolam 0.02mg/kg will be given to every patient for his/her comfort.
Hemodynamic parameters (Heart rate, NIBP and SPO2) will be monitored every 5 minutes for the first half an hour and thereafter every 15 minutes
administration of postoperative analgesic (Inj. Diclofenac 75 mg IV) and Inj. Tramadol 100 mg IV |