| CTRI Number |
CTRI/2018/01/011076 [Registered on: 01/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Single injection vs double injection technique in USG guided supraclavicular brachial plexus block |
|
Scientific Title of Study
|
A comparative analysis of single needle pass two injection technique versus single corner pocket injection technique using Ropivacaine in USG guided supraclavicular brachial plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhanu Pratap Swain |
| Designation |
Assistant Professor |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesiology and Critical Care
Tata Main Hospital
Inner Circle Road
Northern Town
Bistupur
Jamshedpur
Inner Circle Road
Northern Town
Bistupur
Jamshedpur
Pin: 831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9471519719 |
| Fax |
|
| Email |
bhanu_swain@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhanu Pratap Swain |
| Designation |
Assistant professor |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesiology and Critical Care
Tata Main Hospital
Inner Circle Road, Bistupur Northern Town, Bistupur, Jamshedpur
Inner Circle Road
Northern Town
Bistupur
Jamshedpur
Pin:831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9471519719 |
| Fax |
|
| Email |
bhanu_swain@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maneesha Mrigank |
| Designation |
PG student |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesiology and Critical Care
Tata Main Hospital
Inner Circle Road, Bistupur Northern Town, Bistupur, Jamshedpur
Inner Circle Road
Northern Town
Bistupur
Jamshedpur
Pin: 831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7042700710 |
| Fax |
|
| Email |
mrigank.maneesha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Main Hospital
C Road West, Northern Town
Bistupur, Jamshedpur
831001 Jharkhand (IND) |
|
|
Primary Sponsor
|
| Name |
Tata Main Hospital |
| Address |
Inner Circle Road, Northern Town, Bistupur, Jamshedpur, Jharkhand 831001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Maneesha Mrigank |
Department of Anesthesiology & Critical care Tata Main Hospital Inner circle Road Northern town, Bistupur Jamshedpur Jharkhand 831001 |
| Dr Pratap Rudra Mohanty |
Department of Anesthesiology & Critical care
Tata Main Hospital
Inner circle Road
Northern town, Bistupur
Jamshedpur
Jharkhand
831001
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhanu Pratap Swain |
Tata Main Hospital |
Department of Anaesthesia & Critical Care
C Road
Bistupur
Jamshedpur
Purbi Singhbhum
JHARKHAND |
06576641166
bhanu_swain@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Tata Main Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
All patients planned for upper limb surgery under supraclavicular brachial plexus block with in a age group of 17 to 70 years in Tata Main Hospital, (1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1: single needle pass two injection technique of USG guided supraclavicular brachial plexus block |
Nerve block needle will be introduced from lateral to medial in plane with the ultrasound probe in such a manner that the needle will be positioned in the corner pocket formed by the subclavian artery and 1st rib (Imaginary 5 O’ clock position of artery) by passing through the neural cluster. Ropivacaine 0.5% 10 ml will be the injected in the corner pocket after confirming negative aspiration of blood. Then needle will be withdrawn and rest 20 ml of 0.5% Ropivacaine will be injected in the center of the neural cluster. No needle redirection will be done in this technique. |
| Comparator Agent |
Arm 2: Single corner pocket injection technique of USG guided supraclavicular brachial plexus block |
In single injection arm 30 ml of Ropivacaine 0.5% will be injected in the corner pocket formed by the subclavian artery & 1st rib |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 to 3 patients who are planned for forearm surgery
|
|
| ExclusionCriteria |
| Details |
1. Uncooperative patients
2. Patients with neurological disorder or preexistin neurological deficits in the operative limb
3. Patients allergic to Ropivacaine
4. Infection at the site of injection
5. BMI>35
6.Severe coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare onset of block (time to complete sensory and motor block in the distribution of ulnar, median, radial and musculocutaneus nerves) in both arms
|
Sensory and motor blocks will be evaluated post injection every 5 min until 30 min by an anesthesiologist blinded to the technique of injection. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Duration of sensory block:
Duration of motor block:
Duration of analgesia:
Time to perform the block:
Complication if any: |
Duration of sensory block is defined as the time elapsed from onset sensory block to complete recovery of sensation to touch. Duration of motor block is defined as the time elapsed from onset motor block to complete recovery of motor movement in all muscles. Duration of analgesia is defined as the time from the onset of complete block till the patient requires rescue analgesia for the first time.
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2016 |
| Date of Study Completion (India) |
01/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"None yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Ultrasound guided supraclavicular brachial plexus block provides fast onset, complete, safe and reliable anesthesia for upper limb surgery. However there were limited literatures describing the optimal injection technique in the brachial plexus under ultrasound guidance. Few literatures suggest that the single injection of local anesthetics in the corner pocket formed by the intersection between subclavian artery and the 1st rib is enough to get adequate surgical anaesthesia. Others suggested multiple injections to achieve adequate spread of drug in the plexus. However the overall success of surgical anesthesia didn’t differ significantly at the end of 30 minutes. In most places double injection technique of ultrasound guided supraclavicular block (half of total volume of local anesthetic injected in the corner pocket and other half inside the plexus or upper part of brachial plexus) is followed and taught. However double injection technique requires multiple needle passes, which increases patient discomfort. Though single corner pocket injection is associated with less no of needle passes and less procedural time, but associated with delayed onset and sometimes less successful block of the musculocutaneus nerve. Therefore we felt the need to find out a technique that will combine the benefits of both the above techniques to ensure quick and effective block with minimal needle passes. So we modified the double injection technique where two injections are given in a single needle pass. In this technique we injected only 1/3rd of drug (10 ml of Ropivacaine 0.5%) at the corner pocket and rest 2/3rd of drug (20 ml of 0.5% Ropivacaine) in the center of neural cluster while withdrawing the needle. No needle redirection is done during the 2nd injection as needle is just withdrawn in to the neural cluster after injecting in the corner pocket. To find out the effectiveness of this novel technique, we set up a study to compare it with single corner pocket injection technique (30 ml of 0.5% Ropivacaine deposited in the corner pocket formed by 1st rib and subclavian artery) in terms of onset and quality of block. We hypothesise that the two injection technique will lead to quicker and complete block of upper limb than the single injection technique.
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