| CTRI Number |
CTRI/2018/04/013007 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe chronic postsurgical pain in children following major abdominal surgery.
|
|
Scientific Title of Study
|
An observational study on chronic postsurgical pain in children following major abdominal surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parul Upreti |
| Designation |
postgraduate |
| Affiliation |
|
| Address |
Department of anesthesiology, Lady Hardinge Medical College, opposite Shivaji Stadium, Shaheed Bhagat Singh Marg,Connaught Place,New Delhi
Central
DELHI
110001
India |
| Phone |
9910814195 |
| Fax |
|
| Email |
parulupreti64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Hayaran |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of anesthesiology, Lady Hardinge Medical College, opposite Shivaji Stadium, Shaheed Bhagat Singh Marg,Connaught Place,New Delhi
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
hayaran_nitin@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Hayaran |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of anesthesiology, Lady Hardinge Medical College, opposite Shivaji Stadium, Shaheed Bhagat Singh Marg,Connaught Place,New Delhi
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
hayaran_nitin@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Parul Upreti |
| Address |
C-604, Shaheed Bhagat Singh Road, Diz Area, New Delhi, Delhi 110001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parul Upreti |
Lady Hardinge Medical College & Associated Hospitals |
C-604, Shaheed Bhagat Singh Road, Diz Area, New Delhi, Delhi 110001
Central
DELHI |
9910814195
parulupreti64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for Human Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Following Major abdominal Surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II children undergoing major abdominal surgeries
|
|
| ExclusionCriteria |
| Details |
1. Refusal by the parents of the patient
2. Patients having allergy to any drug
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children developing chronic post surgical pain at 3 months following major abdominal surgeries |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity and character of chronic post surgical pain as determined by Revised Bieri’s Faces Pain Scale and as described by patient or parents respectively
|
3 MONTHS |
| Various perioperative factors like acute postoperative pain , perioperative anxiety , surgical technique , duration of surgery and genetic predisposition that can be associated with development of chronic post surgical pain |
2 6 12 24 48HOURS |
| Chronic postsurgical pain trajectory and identifying patients at high risk for development of CPSP |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/12/2016 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Chronic postsurgical pain (CPSP) is defined as pain persisting for more than 3 months after the surgery when all other causes of pain have been ruled out. CPSP in children has found to have significant effects on routineactivities like sleep, social activities and school performance. Although it has been studied in adults there is only limited literature available concerning CPSP in children. The incidence of CPSP varies from 5 to 22% depending on the type of surgery. Incidence of CPSP for major abdominal surgeries varies from 13 to 22%. Various risk factors include acute postoperative pain, perioperative anxiety, surgical technique, durationand genetic predisposition. Since abdominal surgeries are one of the most common surgical procedures performed in routine operation theatre. So we designed this prospective observational study to study the incidence of chronic postsurgical pain in children aged 2 to 8 years following major abdominal surgeries.
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