| CTRI Number |
CTRI/2024/11/077042 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Will resistance to local anaesthetic infiltration predict failure of spinal anaesthesia in patients having history of scorpion sting |
|
Scientific Title of Study
|
Local anaesthesia infiltration to predict failure of spinal anaesthesia in patients with history of scorpion sting-A Prospective Observational study |
| 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 Sandeep Garre |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No G52, Ground floor, Department of Anaesthesiology, All India Institute of Medical Sciences, Bibinagar
Hyderabad
TELANGANA
508126
India |
| Phone |
09989421851 |
| Fax |
|
| Email |
drsandeep189@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D. Ragha Renuka |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no G52, Ground floor, Department of Anaesthesiology, AIIMS-All India Institute of Medical Sciences, Bibinagar
Hyderabad
TELANGANA
508126
India |
| Phone |
|
| Fax |
|
| Email |
ragha345@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Garre |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no G52, Department of Anaesthesiology, All India Institute of Medical Sciences, Bibinagar
Hyderabad
TELANGANA
508126
India |
| Phone |
09989421851 |
| Fax |
|
| Email |
drsandeep189@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bibinagr, Hyderabad Metropolitan Region. Telangana, India, Pin -508126 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bibinagar |
| Address |
All India Institute of Medical Sciences Bibinagar,Hyderabad Metropolitan Region, Telangana, India, Pin - 508126 |
| Type of Sponsor |
Government medical college |
|
|
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 Sandeep Garre |
AIIMS Bibinagar |
Room No G52, Department of Anaesthesiology, All India Institute of Medical Sciences, Bibinagar
Hyderabad
TELANGANA |
09989421851
drsandeep189@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with history of scorpion sting posted for surgery under spinal anaesthesia |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Surgeries under Spinal Anaesthesia
ASA1-3 |
|
| ExclusionCriteria |
| Details |
Allergy to Local Anaesthetics
Contraindications to Spinal anaesthesia if present
Cardiac abnormalities (e.g., severe Aortic stenosis etc)
ASA 4 and 5 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the resistance to local anaesthetic infiltration in predicting failure of spinal anaesthesia in patients with history of scorpion sting.
|
Preoperatively and after giving sub arachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the correlation of interval between scorpion sting and surgery to resistance to local anaesthetics.
2. To assess the correlation between number of scorpion stings and the resistance to local anaesthetics.
|
preoperatively and after giving sub arachnoid block |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Work plan: After obtaining IRC and IEC approval patients with history of scorpion sting meeting the inclusion criteria will be enrolled into the study with patients consent. Testing for resistance to local anaesthesia infiltration will be performed 30-45 mins in advance in the preoperative room. IV access will be obtained, electrocardiogram, pulse oximeter and non-invasive blood pressure will be monitored. All patients will be pre-operatively assessed and patients with history of scorpion sting scheduled to undergo various types of elective surgeries under spinal will be given subcutaneous infiltration of local anaesthetic 0.5 ml of 0.5% Bupivacaine and the area will be marked. Resistance to local anaesthetics will be assessed by sensation to pin prick in the infiltrated area after 5 minutes. If resistance to local anaestheic is present pinprick sensation will be assessed at 10 and 15 minutes. Patients will then be divided into 2 groups: Group R-those who have sensation to pin prick or resistance to local anaesthetics and Group L - those who have loss of sensation to pin prick. Patients will then be shifted to Operation Theatre and preloaded with 1000 ml of RL solution, placed in lateral position and space between 3rd and 4th lumbar spine identified and marked. After taking all aseptic measures lumbar puncture will be done with 25-gauge Quincke’s spinal needle and 15mg of hyperbaric Bupivacaine 0.5% will be administered by an experienced Anaesthesiologist. Immediately, after injection of Bupivacaine patient will be placed in supine position. Electrocardiography, SpO2, heart rate and non-invasive blood pressure monitoring will be done continuously. Sensory block was assessed by pin prick with a 26 gauge hypodermic needle at 1 minute interval. The onset of sensory block was defined as the time when the patient could not feel the pain. Motor block was assessed with Bromage scale.The time for onset, level of sensory, motor block and the efficacy of sub arachnoid block will be assessed in both the groups Those patients in whom there is partial or incomplete effect 20 minutes after subarachnoid block will be given general anaesthesia and will proceed with the surgery Inadequate block can be partial/ unilateral/ insufficient block height or density/ inadequate duration Those patients in whom there is partial or incomplete effect 20 minutes after subarachnoid block will be given general anaesthesia and will proceed with the surgery
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