| CTRI Number |
CTRI/2019/08/020801 [Registered on: 21/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs( ropivacaine and levobupivacaine )in children for relief of pain, with regional block (caudal)in surgery below umbilical under general anaesthesia |
|
Scientific Title of Study
|
Comparison of post-operative analgesia with caudal ropivacaine and levobupivacaine in paediatric patients undergoing infraumbilical surgery under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashi Kumar Gupta |
| Designation |
PG Resident |
| Affiliation |
PGIMER & Dr RML Hospital |
| Address |
Department of anaesthesia PGIMER & Dr RML Hospital
Baba Kharak Singh Marg
New Delhi 110001
INDIA
New Delhi
DELHI
110001
India |
| Phone |
7531047685 |
| Fax |
|
| Email |
shashigupta998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vijay kumar nagpal |
| Designation |
professor |
| Affiliation |
PGIMER & Dr RML Hospital |
| Address |
Department of anaesthesia PGIMER & Dr RML Hospital
Baba Kharak Singh Marg
New Delhi 110001
INDIA
New Delhi
DELHI
110001
India |
| Phone |
7531047685 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.c0m |
|
Details of Contact Person
Public Query
|
| Name |
Shashi Kumar Gupta |
| Designation |
PG Resident |
| Affiliation |
PGIMER & Dr RML Hospital |
| Address |
Department of anaesthesia PGIMER & Dr RML Hospital
Baba Kharak Singh Marg
New Delhi 110001
INDIA
New Delhi
DELHI
110001
India |
| Phone |
7531047685 |
| Fax |
|
| Email |
shashigupta998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of anaesthesia PGIMER Dr RML Hospital baba kharak singh marg new delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
Department of anaesthesia PGIMER & Dr RML Hospital
Baba Kharak Singh Marg New Delhi 110001
INDIA |
| 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 |
| Shashi Kumar Gupta |
PGIMER Dr RMLHospital |
Department of anaesthesia PGI building, Baba Kharak Singh Marg, New Delhi -110001
INDIA
New Delhi
DELHI |
7531047685
shashigupta998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal levobupivacaine |
Patient will be positioned in lateral decubitus position. A dry gauze swab is placed in the anal cleft to protect the anus and genitalia from disinfectants
A triangle will be marked on skin over sacrum, using the posterior superior iliac spines as base, with apex pointing inferiorly(caudally).
Normally this apex sits over or immediately adjacent to the sacral hiatus. The hiatus will be marked and the tip of index finger will be placed on the tip of the coccyx in the anal cleft while the thumb of the same hand will palpate the two sacral cornua
The sacral cornua identified by gently moving he palpating index finger from side to side. The palpating thumb should sink into the hollow between the two cornea, as if between knuckles of a fist
Sterile skin preparation and draping of entire region will be performed to achevie asepsis . A 20G/22G hypodermic needle or caudal cannula will be inserted either in the mid line or para medially into caudal canal.
Feeling of a slight “snap†may be appreciated when advancing needle pierces sacroccygeal ligament.
Once the needle reaches the ventral wall of sacral canal, it is slowly withrawnand turned 90 degree to face cranially, directing it more cranially for further insertion into the canal. Loss of resistance technique will be use to stabilise entry in epidural space then caudal anaesthesia will be given using levobupuvacaine 0.25 % 1ml/k.g.
General anaesthesia will then be reversed using neostigmine (0.05 mg/k.g.) and (0.01 mg/kg) glycopyrolate and patient will be extubated . Patient will be shifted to post anaesthetic care unit till 2 hours after operation |
| Intervention |
Caudal ropivacaine |
Patient will be positioned in lateral decubitus position. A dry gauze swab is placed in the anal cleft to protect the anus and genitalia from disinfectants .
A triangle will be marked on skin over sacrum, using the posterior superior iliac spines as base, with apex pointing inferiorly(caudally).
Normally this apex sits over or immediately adjacent to the sacral hiatus. The hiatus will be marked and the tip of index finger will be placed on the tip of the coccyx in the anal cleft while the thumb of the same hand will palpate the two sacral cornua.
The sacral cornua will be identified by gently moving the palpating index finger from side to side. The palpating thumb should sink into the hollow between the two cornua, as if between two knuckles of a fist
Sterile skin preparation and draping of entire region will be performed to achieve asepsis. A 20G/22G hypodermic needle or caudal cannula will be inserted either in the midline or paramedially into caudal canal.
Feeling of a slight “snap†may be appreciated when advancing needle pierces sacrococcygeal ligament.
Once the needle reaches the ventral wall of sacral canal, it is slowly withdrawn and turned 90 degree to face cranially, Directing it more cranially for further insertion into the canal. Loss of resistance technique will be use to stabilise entry in epidural space then caudal anaesthesia will be given using ropivacaine 0.25 % 1ml/k.g.
General anaesthesia will then be reversed using neostigmine (0.05 mg/k.g.) and (0.01 mg/kg) glycopyrolate and patient will be extubated. Patient will be shifted to post anaesthetic care unit till 2 hours after operation.
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
pediatric patients of either sex with ASA physical status I&II,
2 to 6 yrs of age undergoing infraumbilical surgery |
|
| ExclusionCriteria |
| Details |
local infection at injection site,
Neurological disorders,
allergy to local anaesthetic drug,
sacral or vertebral abnormality,
coagulopathy or anti-coagulation |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quality of analgesia by MOPS Score after administration of 0.25% caudal levobupivacaine
2. Quality of analgesia by MOPS Score after administration of 0.25% caudal ropivacaine
3. Duration of post operative analgesia by time to first rescue analgesia. |
MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2019 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
caudal epidural anaesthesia is a widely used technique in pediatric infraumbilical surgery . use of postoperative analgesia via the caudal epidural route with bupivacaine in pediatric patient is established in infraumbilical surgery . levobupivacaine and ropivacaine provide wider margine of safety , same analgesic effect and less post operative motor block than racemic mixture of bupivacaine in epidural block and both are well tolerated . so we proposed to evaluate the quality and duration of post operative analgesia and any side effects while using caudal block with ropivacaine and levobupivacaine
|