| CTRI Number |
CTRI/2014/09/005023 [Registered on: 15/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
comparison of three different technique of pain relief in one sided abdominal hernia surgery |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF THE ANALGESIC EFFICACY OF ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK, CAUDAL EPIDURAL AND WOUND INFILTRATION IN CHILDREN UNDERGOING UNILATERAL INFRA UMBILICAL 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 |
Mukesh Singh Rautela |
| Designation |
Post Graduate |
| Affiliation |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI |
| Address |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8285965570 |
| Fax |
|
| Email |
mukeshsinghrautela@gmail.cm |
|
Details of Contact Person
Scientific Query
|
| Name |
AMEETA SAHANI |
| Designation |
SENIOR SPECIALIST AND ASSOCIATE PROFESSOR |
| Affiliation |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI |
| Address |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9811201585 |
| Fax |
|
| Email |
AMEETAAS@YAHOO.COM |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Singh Rautela |
| Designation |
Post Graduate |
| Affiliation |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI |
| Address |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8285965570 |
| Fax |
|
| Email |
mukeshsinghrautela@gmail.cm |
|
|
Source of Monetary or Material Support
|
| V.M.M.C AND SAFDARJUNG HOSPITAL NEW DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI |
| Address |
VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI main ot block ground floor dept of anaesthesia vmmc and sjh
DELHI 110029 India
|
| Type of Sponsor |
Government medical college |
|
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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 |
| Mukesh Singh Rautela |
SAFDARJUNG HOSPITAL |
OT 3rd floor,
VMMC AND
SAFDARJUNG
HOSPITAL
South
DELHI
South
DELHI |
8285965570
mukeshsinghrautela@gmail.cm |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, SAFDARJANG HOSPITAL AND VMMC ,NEW DELHI 110029 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA GRADE 1 AND 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients in group C will receive caudal block with 0.25% bupivacaine in a dose of
0.75ml/ kg body weight |
The patient will be placed in the lateral positon with one or both hips flexed,and the saral hiatus palpated . After sterile preparation, a needle (22 Gauge) will be advanced at 60o angle cephalad until a pop is felt as the needle pierces the sacrococcygeal ligament and adavanced 2mm. The needle position will be confirmed by the whoosh test. Aspiration for blood and cerebrospinal fluid will be done to rule out intravascular or intrathecal placement and if negative the calculated amount of local anaesthetic drug will be injected slowly in small aliquots with repeated negative aspiration |
| Comparator Agent |
Patients in group L will receive local wound infiltration with 0.25% bupivacaine in
the line of incision by the surgeon to a maximum of 0.5ml/kg body weight |
At the start of surgery, the surgeon will infiltrate the line of incision with bupivacaine 0.25% upto a maximum of 0.5ml/kg body weight. |
| Intervention |
Patients in group T will receive USG TAP block with 0.25% bupivacaine in a dose
of 0.5ml/kg body weight. |
Skin preparation of the abdomen will be done and the 5-10MHz linear probe will be covered with a sterile plastic cover.The probe will be placed in the horizontal plane just below the umblicius to identify the posterior rectus sheath and the rectus abdominis muscle.
As the probe is moved laterally we will see the distinct plane between external oblique, internal oblique and transversus abdominis muscle.
A 50mm, 22g blunt needle will be inserted in an in-plane approach close to the anterior axillary line, and positioned in the fascial plane between internal oblique and transversus abdominis.
After careful aspiration the predetermined dose of local anaesthetic will be injected .An oval spread in the fascial plane between internal oblique and transversus abdominis will confirm correct placement |
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
. Age 3-10 years and weight less than 20 kg.
2. American Society Anaesthesiology (ASA) physical status I or II.
3. Unilateral lower abdominal surgery such as hernia repair, orchidopexy.
|
|
| ExclusionCriteria |
| Details |
. Contraindications to caudal or TAP block e.g. coagulation defect, systemic or local infection and anatomical abnormalities preventing us from giving any of the above block.
2. History of allergy to bupivacaine and amide local anaesthetic.
3. Children undergoing bilateral lower abdominal surgery or additional surgical procedure at anatomical location not covered by either TAP block or caudal block.
4. Refusal to give consent for study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PULS,BLOOD PRESSURE,OXYGEN SATURATION,END TIDAL CARBON
DIOXIDE,INJ FENTANYL,MAC HOUR,TOTAL FENTANYL/ KG BODY WEIGHT |
BASELINE, AT BLOCK,15min,30min,45min,60min,75min,90min, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PULS,BLOOD PRESSURE,OXYGEN SATURATION,MODIFIED OBJECTIVE PAIN SCORE,TOTAL RESCUE ANALGESIA,PASS URINE, ORAL INTAKE, NAUSEA AND VOMITING |
0,1,2,4,8,12,24hr |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/01/2014 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1 To compare the efficacy and duration of postoperative analgesia between the three study groups using the MOPS (modified objective pain score) score, time to 1st rescue analgesia and total analgesic requirement in 24 hrs.
2 To compare the hospital stay and any delay in discharge among the three groups. |