| CTRI Number |
CTRI/2019/01/016944 [Registered on: 07/01/2019] Trial Registered Prospectively |
| Last Modified On: |
05/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of pruritus after intrathecal administration of Fentanyl. |
|
Scientific Title of Study
|
Incidence of pruritus after administration of intrathecal Fentanyl in orthopaedic surgeries. |
| Trial Acronym |
IPIF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasanti Kelkar |
| Designation |
Associate Prof. |
| Affiliation |
Mahatma Gandhi Mission Medical college and hospital |
| Address |
Plot no. 131, Parimal, Chintamani Housing society, Tilaknagar, Aurangabad
N - 6, CIDCO, Aurangabad
Pin - 431003
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantikelkar70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasanti Kelkar |
| Designation |
Associate Prof. |
| Affiliation |
Mahatma Gandhi Mission Medical college and hospital |
| Address |
Plot no. 131, Parimal, Chintamani Housing society, Tilaknagar, Aurangabad
N - 6, CIDCO, Aurangabad
Pin - 431003
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantikelkar70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasanti Kelkar |
| Designation |
Associate Prof. |
| Affiliation |
Mahatma Gandhi Mission Medical college and hospital |
| Address |
Plot no. 131, Parimal, Chintamani Housing society, Tilaknagar, Aurangabad
N - 6, CIDCO, Aurangabad
Pin - 431003
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantikelkar70@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical college Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM Medical college And Hospital |
| Address |
N-6, CIDCO, Aurangabad,Maharashtra |
| 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 S J Kulkarni |
MGM medical college and hospital |
N 6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA |
9881300645
drsanhitakulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R208||Other disturbances of skin sensation, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving spinal anaesthesia using local anaesthetics & Fentanyl for lower limb orthopaedic surgeries |
|
| ExclusionCriteria |
| Details |
1)Patients having skin disease with pruritus
2)Patients having systemic disease with pruritus
3)Patient receiving antihistaminics or steroids
4)Patients with Opioid dependency
5)Patients with Psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of pruritus |
Intraoperative and postoperative for 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity of pruritus |
at 30 min., 1 hour, 2 hour, 4 hour and 6 hour after administration of intrathecal fentanyl |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
15/01/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients to be posted for lower limb orthopaedic surgeries under spinal anaesthesia will be included in the study. After informed consent, spinal anaesthesia will be given in L3-4 intervertebral space in sitting position. Hyperbaric Bupivacaine (10 - 15 mg) and Fentanyl (25 mcg) will be injected intrathecally. After administration of intrathecal fentanyl, occurence and severity of pruritus will be assessed. Severity of pruritus will be scored from 0-2 (where 0 = no pruritus, 1 = mild to moderate pruritus requiring no treatment, 2 = severe pruritus requiring treatment) at 30 min, 1 hour, 2 hour, 4 hour and 6 hour. Site of pruritus will also be documented. In case of severe pruritus, Inj. Nalbuphine 2 - 3 mg will be given IV. If no response then Inj. Naloxone 0.1 - 0.2 mg will be given. |