| CTRI Number |
CTRI/2024/03/063916 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of single vs triple injection above the clavicle so as to numb the hand for orthopaedic trauma surgery |
|
Scientific Title of Study
|
Comparison of single vs triple aliquot injection for supraclavicular brachial plexus block in upper limb orthopaedic trauma surgeries
: A Randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Babita Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 124 JPNATC,AIIMS Delhi Hospital, Ansari Nagar East Delhi
New Delhi
110029
India
South DELHI 110029 India |
| Phone |
9818302776 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Babita Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 124 JPNATC,AIIMS Delhi Hospital, Ansari Nagar East Delhi
New Delhi
110029
India
South DELHI 110029 India |
| Phone |
9818302776 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
NILIMA MANDAL |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Anesthesiology office, AIIMS Hospital, Ansari Nagar East Delhi
New Delhi
110029
India
South DELHI 110029 India |
| Phone |
09304495962 |
| Fax |
|
| Email |
nilimamandal1306@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , Pain Medicine and Critical Care AIIMS DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Anesthesiology office, AIIMS Hospital, Ansari Nagar East Delhi
New Delhi
110029
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNilima Mandal |
AIIMS Hospital |
Anesthesiology office Room 5011, AIIMS Hospital, Ansari Nagar East Delhi
New Delhi
110029
India South DELHI |
09304495962
nilimamandal1306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee for postgraduate research,AIIMS Delhi |
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 |
Single injection technique supraclavicular block |
Single injection of 15 ml of 0.75 % ropivacaine with 1 mcg/kg clonidine infiltrated around nerves before proceeding for surgery |
| Intervention |
Triple aliquot injection supraclavicular block |
Triple aliquots injection of 0.75% ropivacaine with 1mcg/kg clonidine infiltrated in above,middle and corner pocket in divided dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18-65 years
2) ASA
3)BMI<35kgm2
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal to participate
2)Known allergy to anesthetic drug
3)Infection at local site
4)Pregnancy and breast feeding
5)Known neuropathy involving upper extremities
6)Coagulation disorder
7)COPD and respiratory disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the anesthesia onset time |
5 min 10 min 15 min 20 min 25 min 30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Duration of action
2)Duration of post op analgesia
3)Rate of complications
4)Need for repeat block/rescue analgesia |
Immediate 2h 4h 6h 12h 24h postop day 5 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
19/03/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Supraclavicular block anesthetizes the brachial plexus where it is in its most compact form, thus providing a complete and reliable block for upper extremity surgery.1 Although the single injection (SI) ultrasound-guided corner pocket technique has been reported to have the highest success rate, this technique may miss the upper part of the plexus, resulting in an incomplete block. Cadaver and patient studies by using dye injections have demonstrated that injection into a single location does not result in the spread of the injected dye into all the compartments. Septae or a tight muscular membrane between the scalene muscles were found to separate roots of the plexus. Several studies comparing different approaches for brachial plexus block have demonstrated multiple injection techniques to be more successful, resulting in a faster onset of anesthesia and higher success rates with no increased incidence in complications. However, these trials did not show consistent results regarding the onset of block or the nerves blocked. The aim of this study was to compare the sensory block success rate of SI versus triple injection (TI). We hypothesized that a TI performed at the upper, middle, and lower parts of the plexus would have a higher success rate compared with the SI technique. In single injection using in plane approach a 22g 5 cm needle will be advanced until the tip is at the junction of first rib and subclavian artery.15 ml of 0.75% ropivacaine with 1 mcg/kg clonidine will be injected with negative aspiration. Similarly for triple injection 5 ml each of the drug will be injected in corner , middle and above pocket. The time of onset of block will be measured as the primary outcome. We hypothesized that triple injection is more efficacious than single injection. |