| CTRI Number |
CTRI/2024/04/065947 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
USG versus Combined PNS and USG guided Axillary Nerve Block in patients undergoing Upper limb surgeries |
|
Scientific Title of Study
|
A comparison of Ultrasonography guided Axillary nerve block Versus Combined Peripheral nerve stimulator and Ultrasonography guided Axillary nerve block in patients undergoing upper limb surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Padala Sri sai Kamala Harika |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9603023224 |
| Fax |
|
| Email |
psskharika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yerramsetti Atchyuth Ramaiah |
| Designation |
Associate Professor |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9949924203 |
| Fax |
|
| Email |
yerramsetti.atchyuth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Padala Sri sai Kamala Harika |
| Designation |
Resident |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9603023224 |
| Fax |
|
| Email |
psskharika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Rangaraya Medical College,
Kakinada, East Godavari - 533001. |
|
|
Primary Sponsor
|
| Name |
Padala Sri sai Kamala Harika |
| Address |
Department of Anaesthesiology,
Rangaraya Medical College,
Kakinada |
| 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 |
| Padala Sri sai Kamala Harika |
Government General Hospital, Kakinada |
Orthopedics Operation Theatre Complex,
Department of Anaesthesiology,
Rangaraya Medical College,
Kakinada
East Godavari
ANDHRA PRADESH |
9603023224
psskharika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rangaraya Medical College institutionsl ethics committee cell |
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 |
| Intervention |
Ultrasound guided Axillary nerve block |
20ml 0.5% Ropivacaine given once unilaterally by multiple injection technique |
| Intervention |
Ultrasound plus Peripheral Nerve Stimulator guided Axillary Nerve block |
20ml 0.5% Ropivacaine given once unilaterally by multiple injection technique |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1&2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Latency by Modified Lovett Muscle Power Scale and Numerical Rating Scale for pain |
0mins
1min
2mins
3mins
5mins
7mins
10mins
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for supplementary analgesic agent by using Numerical Rating Scale for pain |
0min
1hour
2hour
4hour
6hour
8hour
12hour
16hour
20hour
24hour |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/06/2024 |
| 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="0"
Months="10"
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
|
The effectiveness of electrical nerve stimulation of evoked motor responses has been called into doubt because ultrasonography is now frequently used to localise nerves during peripheral nerve blocking. Nerve stimulation’s function has evolved from that of a method for locating nerves to that of an addition to ultrasonography. When using ultrasound guided procedures, nerve stimulation may be effective as a safeguard against needle-nerve contact and as a means of avoiding nerves that are in the needle’s trajectory. When the position or appearance of the nerves may be varied, nerve stimulation is also a helpful adjunct in training amateurs in ultrasound-guided regional anaesthesia. Hence for surgeries involving elbow and forearm both USG and pns vs only USG guided Axillary nerve block is given. And the efficacy of the block is assessed in the terms of time taken to perform the block, occurrence of LAST, Intraneural injections, onset of sensory and motor blockade in both procedures which is assessed by NRS SCALE and LOWETT muscle power scale.
|