| CTRI Number |
CTRI/2024/04/066393 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Observational Study to determine the minimum effective volume of Local Anesthetic Needed for Ultrasound Guided Supraclavicular Brachial Plexus Block |
|
Scientific Title of Study
|
A Randomized Observational Study to determine the minimum effective volume of Local Anesthetic Needed for Ultrasound Guided Supraclavicular Brachial Plexus Block |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Jha |
| Designation |
Junior Resident |
| Affiliation |
BJGMC and SGH Pune |
| Address |
Dept of Anesthesiology, BJGMC and SGH
Pune
MAHARASHTRA
411001
India
Pune
MAHARASHTRA
411001
India |
| Phone |
08983741147 |
| Fax |
|
| Email |
nj96kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
BJGMC and SGH, Pune |
| Address |
Trauma ICU, Department of trauma care centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road
Pune
MAHARASHTRA
411001
India
Pune
MAHARASHTRA
411001
India |
| Phone |
08983741147 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
BJGMC and SGH, Pune |
| Address |
Trauma ICU, Department of trauma care centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road
Pune
MAHARASHTRA
411001
India
MAHARASHTRA
411001
India |
| Phone |
08983741147 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sassoon General Hospital, Pune |
|
|
Primary Sponsor
|
| Name |
Neha Jha |
| Address |
Dept of Anesthesiology, BJGMC and SGH
Pune
MAHARASHTRA
411001
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sujit Kshirsagar |
Sassoon General Hospital, Pune |
Trauma Operation theatre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
08983741147
bjsujit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, B.J. Govt. Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supraclavicular brachial plexus block |
20 cc of Inj. Lignocaine Adrenaline 2% and Inj. Bupivacaine 0.5% |
| Comparator Agent |
Supraclavicular brachial plexus block |
25 cc of Inj. Lignocaine Adrenaline 2% and Inj. Bupivacaine 0.5% |
| Comparator Agent |
Supraclavicular brachial plexus block |
30 cc of Inj. Lignocaine Adrenaline 2% and Inj. Bupivacaine 0.5% |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists physical status I-II
2. Patients schedule for upper limb surgery
3. Ultrasound visibility score equal or greater than 10
|
|
| ExclusionCriteria |
| Details |
1. ASA III and IV
2. Pregnant Patients
3. Patients with coagulation disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the minimum effective volume of LA for ultrasound guided supraclavicular block |
Baseline, 15 min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study onset time for sensory block
2. To study onset time for motor block
3. To study onset time to achieve complete block
4. To study complications if any |
Baseline, 15 min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min. |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
06/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For upper limb surgery, supraclavicular block offers excellent anesthetic [1,2]. Additionally, the use of ultrasound guiding during supraclavicular block has been developed and is growing in acceptance [3]. Numerous benefits of ultrasound-guided supraclavicular block include higher success rates, quicker onset times, and less problems [4-6]. The possibility of using less local anesthetic was shown in earlier investigations on ultrasound-guided axillary blocks and interscalene blocks [7–10]. However, there is significant debate regarding the ultrasound-guided supraclavicular block’s use of a lower anesthetic amount [11,12]. The Dixon and Massey up and down method (DUDM) and biased coin design up and down method (BUDM) were used to calculate the minimum effective volumes (MEV) 50, MEV90, and MEV95, respectively, in previous studies on the minimum effective volume for the ultrasound-guided supraclavicular block [11,12]. Statistics was used to estimate these effective amounts. The comparison of the various anesthetic volumes in the clinical practice for the ultrasound-guided supraclavicular block has not been explored, and Orebaugh et al. [13] noted that the results from the DUDM may differ from those of the actual practice. This study’s objective is to analyse clinical data in relation to different local anesthetic dosages used during an ultrasound-guided supraclavicular block. |