| CTRI Number |
CTRI/2013/01/003311 [Registered on: 21/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/09/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON BETWEEN CAUDAL EPIDURAL BLOCK AND POPLITEAL NERVE BLOCK FOR AFTER OPERATIONS PAIN IN CHILDREN UNDERGOING FOOT OPERATION |
|
Scientific Title of Study
|
COMPARISON BETWEEN CAUDAL EPIDURAL BLOCK AND POPLITEAL NERVE BLOCK FOR POSTOPERATIVE ANALGESIA IN CHILDREN UNDERGOING FOOT SURGERY |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tailang Bumer |
| Designation |
junior resident |
| Affiliation |
AIIMS |
| Address |
anaesthesia department, AIIMs, New delhi
AB-8, AIIMs, New delhi
South
DELHI
110029
India |
| Phone |
09910557387 |
| Fax |
00911126588663 |
| Email |
www.bumerxp786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lokesh Kashyap |
| Designation |
professor |
| Affiliation |
AIIMS |
| Address |
anaesthesia department, AIIMs, New delhi
5th floor, AIIMS ,anaesthesia department
South
DELHI
110029
India |
| Phone |
09868397821 |
| Fax |
00911126588641 |
| Email |
lokeshkashyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lokesh Kashyap |
| Designation |
professor |
| Affiliation |
AIIMS |
| Address |
anaesthesia department, AIIMs, New delhi
5th floor, AIIMS ,anaesthesia department
South
DELHI
110029
India |
| Phone |
09868397821 |
| Fax |
00911126588641 |
| Email |
lokeshkashyap@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences hospital |
| Address |
All india institute of medical sciences, hospital, Ansari nagar,new delhi,110029 |
| Type of Sponsor |
Government 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 |
| Tailang bumer |
orthopaedics operation theatre and wards |
orthopaedics operation theatre and wards, 1st floor, AIIMS, New Delhi
South
DELHI |
09910557387
00911126588663
www.bumerxp786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee/sub-ethics committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
undergoing foot surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
1 ml/kg of Bupivacaine 0.25% will be used in both Caudal epidural block and popliteal nerve block |
| Intervention |
Group A: caudal epidural block |
GROUP A:Caudal epidural block: Patient will be turned to lateral position .A short beveled needle of 22G or 23G will be used. After antiseptic dressing and draping sacral cornua and hiatus felt and needle will be inserted at the sacral hiatus at an angle 45 to skin directing cephalad. Caudal epidural space is identified by the loss of resistance once the needle has passed the sacrococcygeal ligament. 1 ml/kg of Bupivacaine 0.25% will be injected after negative aspiration.
|
| Intervention |
Group B: popliteal nerve block |
GROUP B: popliteal nerve block: Child in supine position with leg flexed at hip and knee or in lateral position, a triangle is constructed with skin crease behind the knee as base and two sides by the semimembranosus (medially) and the biceps femoris (laterally). A bisecting line is drawn from apex to the base of the triangle. The needle is advanced at a 45 degree angle aiming cephalad just lateral to bisecting line of the triangle until nerve stimulator is elicited. Distance from the base of triangle to needle insertion is estimated based on weight. If the weight is less than 10 kg, than the distance is 1 cm, if the weight is 10-20 kg, than the distance is 2 cm and for each 10 kg increment in weight, needle should move approximately 1 cm cephalad in the triangle |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
. Age 1 – 12 years
. ASA – I/II status
. Elective surgeries in foot surgery
|
|
| ExclusionCriteria |
| Details |
. Refusal by parents or guardians for their wards to participate in study
. Children undergoing emergency surgeries
. Children with peripheral nerve disorders
. History of allergy to local anaesthetics
. Presence of spinal deformities
. History of any bleeding disorder
. Presence of local infection at the site of caudal block
. History of any derangement of liver or renal functions
. Presence of URTI
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain assess by CHEOPS (Childrens Hospital of Eastern Ontario Pain Scale) and VAS(visual analogue scale |
CHEOPS (Childrens Hospital of Eastern Ontario Pain Scale) and VAS(visual analogue scale) at recovery room, 1hr, 4 hr, 8 hr, 12 hr, 18hr and 24 hr post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nausea , vomiting,agitation,sedation,haematoma,parental satisfaction |
at recovery room, 1hr, 4 hr, 8 hr, 12 hr, 18hr and 24 hr post operatively |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/07/2012 |
| 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="2"
Months="5"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized single blind study, comparing caudal epidural block and popliteal nerve block for postoperative analgesia in children undergoing foot surgery with1 ml/kg of 0.25% bupivacaine. All study will be conducted in AIIMS, New Delhi, India. primary outcome thats is postoperative pain will be assess by CHEOPS and VAS ; secondary outcome like nausea, vomiting,agitation,sedation,haematoma and parenteral satisfaction will also be assessed upto 24 hours postoperatively. |