| CTRI Number |
CTRI/2025/01/079429 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of pruritus among different types of surgeries after injecting morphine in spinal anaesthesia |
|
Scientific Title of Study
|
EFFECT OF TYPE OF SURGERY ON
THE INCIDENCE OF PRURITUS
FOLLOWING 100 mcg INTRATHECAL
MORPHINE IN ADULTS AN
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 |
Ajay Nalluri |
| Designation |
Post Graduate Resident |
| Affiliation |
JSS medical College and Hospital |
| Address |
Dept of Anaesthesiology Critical care
JSS Hospital
Mahatma Gandhi Road
Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
8121528565 |
| Fax |
|
| Email |
ajay.nalluri.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sarika M Shetty |
| Designation |
Associate Professor |
| Affiliation |
JSS medical College and Hospital |
| Address |
Dept of Anaesthesiology Critical care
JSS Hospital
Mahatma Gandhi Road
Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
8121528565 |
| Fax |
|
| Email |
drsarikamshetty@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajay Nalluri |
| Designation |
Post Graduate Resident |
| Affiliation |
JSS medical College and Hospital |
| Address |
Dept of Anaesthesiology Critical care
JSS Hospital
Mahatma Gandhi Road
Mysuru
KARNATAKA
570004
India |
| Phone |
8121528565 |
| Fax |
|
| Email |
ajay.nalluri.7@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS academy of higher education, Bannimantap, Mysuru 570015 |
|
|
Primary Sponsor
|
| Name |
JSS academy of higher education |
| Address |
JSSAHER,JSS MEDICAL CAMPUS,S.S NAGAR, BANNIMANTAP,MYSURU 570015 |
| Type of Sponsor |
Private 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 AJAY NALLURI |
JSS HOSPITAL |
operation theatre complex,3rd floor, JSS hospital
Mysore
KARNATAKA |
8121528565
ajay.nalluri.7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
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 |
intrathecal morphine |
100mcg intrathecal morphine to the patients recieving spinal injection |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 20-60 years who are scheduled for below umbilical
surgeries i.e, patients posted for gynaecological surgeries, orthopaedic and general surgeries
belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) class I & II
under spinal anaesthesia will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients aged less than 20 years and more than 60 years with ASA grading gretaer than or equal to 3, and surgeries with spinal anaesthesia converted to general anaesthesia,BMI gretaer than 30 , patients with prior history of itching and other dermatalogical disorders are excluded from the study |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pruritus followed by intra thecal administration of morphine |
from sub archanoid block to 24 hours post operative monitoring. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nause and vomiting followed by intra thecal administration of morphine |
from sub archanoid block to 24 hours post operative monitoring. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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="8"
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
|
Patients will be evaluated thoroughly as a part of the pre anaesthetic evaluation. Thorough airway assessment, relevant investigations will be checked and the vitals will be recorded.Patients assessed for the study eligibility & Patients meeting the criteria are selected, shifted to the operating room. All subjects under study will receive Inj BUPIVACAINE 15mg + Inj MORPHINE 100 mcg intrathecally. Post surgery patients are shifted to the recovery room , followed for 24 hours and signs of pruritus, nausea & vomiting are noted by the recovery room clinician and graded according to the pruritus grading system. |