| CTRI Number |
CTRI/2013/08/003915 [Registered on: 23/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
19/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower Abdominal and pelvic surgeries in paediatric surgical cases |
|
Scientific Title of Study
|
To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower Abdominal and pelvic surgeries in paediatric surgical cases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aruna Bharti |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology
Sanjay Gandhi Post Graduate Institute of Medical Sciences -Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
05222495262 |
| Fax |
91-522-2668017 |
| Email |
arunabha@sgpgi.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aruna Bharti |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology
Sanjay Gandhi Post Graduate Institute of Medical Sciences-Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
05222495262 |
| Fax |
91-522-2668017 |
| Email |
arunabha@sgpgi.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Aruna Bharti |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology
Sanjay Gandhi Post Graduate Institute of Medical Sciences -Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
05222495262 |
| Fax |
91-522-2668017 |
| Email |
arunabha@sgpgi.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SPGIMS Lucknow |
| Address |
S.P.G.I.M.S. Raibarelliroad Lucknow-226014
Uttar Pradesh (India) |
| 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 Aruna Bharti |
Sanjay Gandhi Post Graduate Institute of Medical Sciences- Lucknow |
Paediatric Surgery Ward and Paediatric Surgery Operation Theater(O.T.-4),A-Block Sanjay Gandhi Post Graduate Institute of Medical Sciences-
Raebarelliroad Lucknow-226014 Lucknow UTTAR PRADESH |
05222495262 91-522-2668017 arunabha@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sanjay Gandhi Post Graduate Institute of Medical Sciences,Lucknow Registered with DCGI with registration number of ECR/16/Inst/UP/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
who are undergoing for lower Abdominal and pelvic surgeries in paediatric surgical cases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
preoperative analgesic suppositories of paracetamol which will be given following induction of general anaesthesia |
Group II the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative analgesic suppositories of paracetamol in the dose of 10mg/kg body weight which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl 2mcg/kg)for control of pain sign/symptoms as rescue analgesic |
| Intervention |
preoperative caudal epidural block |
Group- I, in which the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative caudal epidural block with 1.5 mg/kg of 0.25% bupivacaine which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl 2mcg/kg)for control of pain sign/symptoms as rescue analgesic |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1-unpremedicated,
2-ASA class- I paediatric surgical patients of
either sex
3-age between 5-16 yrs
4-can able to understand and comprehend the visual analogue Wong-Baker Faces Scale scoring system
5-undergoing lower abdominal or pelvic surgery |
|
| ExclusionCriteria |
| Details |
1-more than ASA Grade I
2-Age below 5 years and age above 16 years 3-Contraindication to caudal epidural block 4-inability to comprehend the visual analogue Wong-Baker Faces Scale scoring system with visual analogue number rating scoring system |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases |
1, 2, 24 hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nausea and vomiting will also be noted.Rescue medication (i/v fentanyl 1 microgram/kg) has to be administered if the VAS pain score exceeded 50 at any time. The times from injection to first unsupported standing after anaesthesia and hospital discharge will also be documented |
1, 2, 24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/10/2012 |
| 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) |
Open to Recruitment |
|
Publication Details
|
yet not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim: “To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower abdominal and pelvic surgeries in paediatric surgical case Justification for the study:- Here we are trying to study and comparing the efficacy of two different types of analgesic techniques for postoperative pain relief after lower abdominal and pelvic surgeries in paediatric surgical cases.The expected outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases methodology - we intend to enrol 80 unpremedicated, ASA class- I paediatric surgical patients of either sex (age between 5–16years) undergoing lower abdominal or pelvic surgery will be included in this study; they will be divided into two groups of 40 each using a randomization chart. Group- I, in which the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative caudal epidural block which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl) for control of pain sign/symptoms as rescue analgesic. While in Group II the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative analgesic suppositories of paracetamol which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl) for control of pain sign/symptoms as rescue analgesic. All the recruited patients were instructed on proper use of the visual analogue sliding scale (vas scale) system [0= no pain, 100=worst pain imaginable] at the time PAC a day before surgery as well as again on arrival in the induction room. All the patients were randomized to receive any one of the above two mentioned techniques to get post operative pain relief .The time of injection of drug (via caudal epidural and via rectal route in the form of suppository) is to be noted and surgical incision will be allowed after at least 15 minutes had been elapsed subsequently. The pain relief would be deemed unsuccessful if there is a persistant increase of more than 30% in heart rate or mean arterial blood pressure values above baseline following surgical incision. These patients will be given intravenous fentanyl 1microgm/kg and will be withdrawn from the study. At the end of the surgery all anaesthetics will be stopped and 100% oxygen will be administered. VAS pain scores will be elicited upon emergence from anesthesia,and at 1 ,2and 24hrs postoperatively after injection of analgesic drug (via caudal epidural and via rectal route in the form of suppository) by blinded investigator. Other adverse events such as nausea and vomiting will also be noted. Rescue medication (i/v fentanyl 1 microgram/kg) has to be administered if the VAS pain score exceeded 50 at any time. Other parameters to be studied are quality of night sleep, adverse effects of analgesics, recovery of bowel and bladder function, economic impact and morbidity related to the two techniques.
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