| CTRI Number |
CTRI/2025/10/096332 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to find out how often itching happens and what factors make it more likely, and where on the body it usually appear in participants who receive spinal anesthesia using fentanyl with bupivacaine |
|
Scientific Title of Study
|
Incidence risk factors and pattern of distribution of pruritis in patients receiving intrathecal fentanyl as an adjuvant to spinal anaesthesia with hyperbaric bupivacaine
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sparsh singhal |
| Designation |
junior resident |
| Affiliation |
kmc manipal |
| Address |
department of anaesthesia kmc manipal udupi karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8171009430 |
| Fax |
|
| Email |
sparshsinghal11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhma T.K |
| Designation |
Additional professor |
| Affiliation |
kmc manipal |
| Address |
department of anaesthesia kmc manipal udupi karnataka
KARNATAKA
576104
India |
| Phone |
99646 20729 |
| Fax |
|
| Email |
drsushmagowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sparsh singhal |
| Designation |
junior resident |
| Affiliation |
kmc manipal |
| Address |
department of anaesthesia kmc manipal udupi karnataka
KARNATAKA
576104
India |
| Phone |
8171009430 |
| Fax |
|
| Email |
sparshsinghal11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sparsh singhal |
| Address |
department of anaesthesia kmc manipal udupi karnataka |
| 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 |
| sparsh singhal |
Kasturba medical college manipal |
department of anaesthesia kMC manipal udupi karnataka
Udupi
KARNATAKA |
08171009430
sparshsinghal11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients undergoing surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with allergy to opioids
preexisting pruritis; preeclampsia; diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of pruritic with intrathecal fentanyl |
during operative and one hour post operative duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to look for risk factors associated and pattern of distribution of pruritis with intrathecal fentanyl |
during operative and one hour post operative duration |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/11/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
In this study, patients undergoing surgery under spinal anaesthesia
will receive intrathecal bupivacaine with fentanyl as additive as a part of
standard protocol of our institution, and the occurrence of pruritus (itching)
will be assessed. ,
the procedure will be explained to the participant in detail and informed consent will be
taken. No specific orders to be followed for the sake of our study as it is
purely an observational study which does not involve any painful procedure. In
the operation theatre just before surgery patients receiving spinal anaesthesia
with bupivacaine with
fentanyl will be assessed for severity of itching and site of itching |