| CTRI Number |
CTRI/2024/11/076511 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of reducing Anxiety on block success in upper limb surgery |
|
Scientific Title of Study
|
Evaluate the Effect of Different Methods of Anxiolysis on Ultrasound Guided Brachial Plexus Block Success in Patients undergoing Upper Limb Surgery |
| 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 Ruchi Gupta |
| Designation |
Professor and head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
OT no-8 and 9, Main OT, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
09814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhdeep |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main OT, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8847271789 |
| Fax |
|
| Email |
shubhdeep999@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shireen Hanjra |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
OT no-8 and 9, Main OT, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8146999222 |
| Fax |
|
| Email |
shireenhanjra13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Operation Theatre, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah,Amritsar. 143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah,Amritsar. 143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Ruchi Gupta |
Operation Theatre |
Main OT, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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 |
Antianxiolytic treatment before block |
Councelling of the patient before administering block |
| Intervention |
Antianxiolytic treatment before block |
Intravenous Injection Midazolam 2mg diluted to 5ml with NS, 10 min before administering block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA grade I and II
2 Scheduled for elective upper limb extremity surgeries. |
|
| ExclusionCriteria |
| Details |
1 Patients having skin infection at the needle puncture site.
2 Patients suffering from coagulopathies / bleeding disorders
3 Patients with history of neuropathies
4 Pregnant patients.
5 Patients hypersensitive to the drugs being used in the study.
6 Difficulty reading or understanding the anxiety form, mental illness, or psychiatric disease
7 Patients already on any sedative hypnotic’s medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Block Faliure |
from initiation of block to the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sparing of Dermatome, postoperative analgesia requirement |
initiation of block to 24 hour postoperative |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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="6"
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
|
Introduction: Preoperative anxiety is common and can affect surgical outcomes. The APAIS test is used to measure anxiety levels and need for information. Regional anesthesia, like brachial plexus block, is preferred for upper limb surgeries due to fewer side effects. However, anxiety can still affect patients, impacting block success. Ultrasound guidance improves outcomes but doesn’t eliminate block failure, prompting research into anxiety management’s impact on block success. Aims: The aim of the study is to assess the effect of various anxiety reduction methods on the success of ultrasound-guided brachial plexus block in upper limb surgery patients. Objective of the study is to investigate and compare the impact of counselling, and injection midazolam on ultrasound-guided brachial plexus block performance Methodology: Randomized controlled study will be conducted in 100 patients undergoing upper limb surgery under ultrasound guided brachial plexus block. Patients will be randomly divided into 2 groups of 50 each group A receiving preoperative counciling and group B receiving preoperative midazolam, patients will be evaluated for anxiety with HAM-A and APAIS in the preoperative area. Significance of the study: Explore various interventions to ease anxiety and enhance outcomes in ultrasound-guided brachial plexus block for upper limb surgeries |