| CTRI Number |
CTRI/2017/01/007714 [Registered on: 16/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study on Chronic pain in children undergoing inguinal hernia repair |
|
Scientific Title of Study
|
An Observational study on Chronic Post Surgical Pain in children undergoing unilateral inguinal hernia surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Nagar |
| Designation |
Post graduate junior resident |
| Affiliation |
Lady Hardinge Medical College and Associated hospitals |
| Address |
Room No. 208, RMO-A,
Lady Hardinge Medical College,
New Delhi
New Delhi DELHI 110001 India |
| Phone |
9711674404 |
| Fax |
|
| Email |
deepika151088@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajai Kumar |
| Designation |
Director professor |
| Affiliation |
Lady Hardinge Medical College and Associated hospitals |
| Address |
Department of Anaesthesiology,
Lady Hardinge Medical College,
New Delhi, 110001 Department of Anaesthesiology,
Lady Hardinge medical college & associated hospitals,
New Delhi, 110001 New Delhi DELHI 110001 India |
| Phone |
9899589275 |
| Fax |
|
| Email |
drajaikumar11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deepika Nagar |
| Designation |
Post graduate junior resident |
| Affiliation |
Lady Hardinge Medical College and Associated hospitals |
| Address |
Room No. 208, RMO-A,
Lady Hardinge Medical College,
New Delhi
New Delhi DELHI 110001 India |
| Phone |
9711674404 |
| Fax |
|
| Email |
deepika151088@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College and Associated hospitals,shaheed bhagat singh marg, New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
Lady hardinge medical college and associated hospitals |
| Address |
Lady Hardinge Medical College and associated hospitals,
Shahid Bhagat Singh Marg,
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepika Nagar |
Kalawati saran childrens hospital |
KSCH Operation Theater, Lady Hardinge Medical College and associated hospitals,
Shaheed Bhagat Singh Marg,
New Delhi New Delhi DELHI |
9711674404
deepika151088@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for human research, Lady Hardinge Medical College and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children aged 2-8 years undergoing unilateral inguinal hernia surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II children aged 2-8 years undergoing unilateral inguinal hernia surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
• Refusal by the parents of the patient.
• Patients having allergy to any drug.
• Patients with previous surgery at same site.
• Patients with any major systemic disease.
• Surgery lasting more than 90 minutes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of chronic post surgical pain in children aged 2-8 years at 3 months after undergoing unilateral inguinal surgery |
3 months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of acute postoperative pain in children aged 2-8 years undergoing unilateral inguinal hernia surgery |
24 hours postoperatively |
| Severity and character of chronic postsurgical pain in children aged 2-8years undergoing unilateral inguinal hernia surgery |
3 months postoperatively
|
| Factors affecting chronic postsurgical pain |
Till 3 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="113" Sample Size from India="113"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational prospective study on chronic postsurgical pain in children undergoing unilateral inguinal hernia surgery. ASA
grade I & II children aged 2-8 years undergoing unilateral inguinal hernia
surgeries under general anaesthesia were included in the study population. After pre anaesthetic
checkup written informed consent was taken from parents/guardian of the patients. Anaesthesia was administered the institutional protocols including oral midazolam (0.5mg/kg) administered 30 minutes prior to surgery & surgery was conducted under GA
with any of the three blocks (Caudal, INB, PVB) as per the choice of the
consultant anaesthesiologist. Patients were shifted to the recovery room after
surgery and acute post operative pain was assessed by observation of FLACC (Face, Legs, Activity, Cry, Consolability) Score at 0, 2, 4, 6, 12 and 24 hours. They were followed up at three months following surgery for assessment of chronic postsurgical pain using revised Bieri’s faces pain scale. Various factors were studied for any association with chronic postsurgical pain including - age, gender, duration of surgery, surgeon’s experience, anaesthetic technique used, and acute postoperative pain. |