CTRI Number |
CTRI/2023/03/050396 [Registered on: 06/03/2023] Trial Registered Prospectively |
Last Modified On: |
12/04/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial to study selective nerve block versus axillary plexus block for control of upper limb pain due to trauma |
Scientific Title of Study
|
Efficacy of ultrasound-guided selective peripheral nerve block
compared to axillary brachial plexus block for control of pain due to upper
extremity trauma: A randomized controlled trial |
Trial Acronym |
NA |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Chitta Ranjan Mohanty |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
Address |
Department of Trauma and Emergency
Room No 405 Academic 4th floor
AIIMS, BBSR
Sijua
Khordha ORISSA 751019 India |
Phone |
8280458275 |
Fax |
|
Email |
drchitta8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Chitta Ranjan Mohanty |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
Address |
Department of Trauma and Emergency
Room No 405
4th floor academic block
Sijua
Khordha ORISSA 751019 India |
Phone |
8280458275 |
Fax |
|
Email |
drchitta8@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Chitta Ranjan Mohanty |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
Address |
Department of Trauma and Emergency
4th floor Academic block
Sijua
Khordha ORISSA 751019 India |
Phone |
8280458275 |
Fax |
|
Email |
drchitta8@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences Bhubaneswar |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Bhubaneswar |
Address |
AIIMS Bhubaneswar
SIJUA 751019 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
All India Institute of Medical Sciences Bhubaneswar |
AIIMS Bhubaneswar
SIJUA 751019 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Chitta Ranjan Mohanty |
All India Institute of Medical Sciences Bhubaneswar |
Department of Trauma and Emergency
Ground Floor
Sijua 751019 Khordha ORISSA |
08280458275
drchitta8@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR |
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | peripheral nerve block | (Procedure Reference: peripheral nerve block, Procedure details: ultrasound-guided peripheral nerve block, Procedure details: The patient will be positioned as per the requirement of the specific nerve block. 7.5 MHz linear transducer will be used for anatomical location and performance of nerve block. Upon identification of the respective nerve, a 22-gauge, 5-cm stimuplex needle (B-Braun Medical Inc, Geermany) will be inserted in-plane technique. After negative aspiration 2.5-3 ml of 0.375% ropivacaine will be injected near the nerve.) The duration of inteve)
| 2 | Comparator Arm (Non Ayurveda) | | - | Axillary brachial plexus block | Axillary brachial plexus block will be performed under ultrasound guidance using 0.375% ropivacaine. The stimuplex needle will be introduced under ultrasound guidance near the nerve and the drug will be injected around the nerve plexus after negative aspiration. The total duration of intervention will be 10 to 20 minutes |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
(i)Upper extremity injury with pain score of ≥ 5 in Numerical rating scale (NRS).
(ii)Able to consent and actively participate in the study.
|
|
ExclusionCriteria |
Details |
(i) Patient refusing consent to participate in the study.
(ii) Any contraindication for regional anesthesia.
(iii) Multiple limb injury.
(iv) Any pre-existing neurological illness which can be due to which the patient has an abnormal appreciation of pain stimulus.
(v) Patient unable to understand the NRS score.
(vi) Patient with polytrauma needing urgent surgery or surgery within the possible duration of the study
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Assessment of pain score by NRS |
At 30 minutes, one hour, two-hour, three-hour, four hour and six hours after the block |
|
Secondary Outcome
|
Outcome |
TimePoints |
Sensorimotor evaluation |
At 30 minutes, one hour, two-hour, three-hour, four hour and six hours after the block |
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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)
|
13/03/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This randomised open labeled trial will compare efficacy of ultrasound guided axillary plexus block with selective peripheral nerve block. Ninety-four patients who met the inclusion criteria will be included for the study. They will be randomly divided into two groups based on a computer-generated randomised sequence and allocated in two groups by SNOSE technique. Primary outcome will be pain assed in NRS at 30 minutes after performing the nerve or plexus block. |