| CTRI Number |
CTRI/2023/01/048753 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy between two Local anesthetic drugs[0.25 % BUPIVACAINE and 0.25% LEVOBUPIVACAINE] for caudal anesthesia in pediatric patients for below umbilical surgeries |
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Scientific Title of Study
|
COMPARISON OF EFFICACY BETWEEN 0.25% BUPIVACAINE AND 0.25% LEVOBUPIVACAINE FOR CAUDAL ANESTHESIA IN PEDIATRIC INFRAUMBILICAL SURGERIES
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaisima Balaji S |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of anesthesiology Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7708787091 |
| Fax |
|
| Email |
jaibalaji39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suneeth P Lazarus |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of anesthesiology Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894332543 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaisima Balaji S |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of anesthesiology Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7708787091 |
| Fax |
|
| Email |
jaibalaji39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107 |
|
|
Primary Sponsor
|
| Name |
Jaisima Balaji S |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JAISIMA BALAJI S |
Sri manakula vinayagar medical college and hospital |
Department of anesthesiology
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107
Pondicherry
PONDICHERRY |
7708787091
jaibalaji39@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE |
0.75ml/kg of 0.25% bupivacaine will be administered.Duration ofanalgesia,duration of motor blockade,hemodynamic parameters and incidence of adverse effects will be studied |
| Intervention |
LEVOBUPIVACAINE |
0.75ml/kg of 0.25% levobupivacaine will be administered.Duration ofanalgesia,duration of motor blockade,hemodynamic parameters and incidence of adverse effects will be studied |
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective infraumbilical surgeries.
Age between 2 years to 8 years of either sex.
Weight between 9 to 35kg.
Anticipated duration of surgery <60 minutes.
ASA grade І or Ⅱ. |
|
| ExclusionCriteria |
| Details |
Emergency surgeries.
Known hypersensitivity to amide local anaesthetics.
History of active neurological, cardiac, respiratory and renal diseases.
Blood dyscrasia, clotting disorders and platelet count <100000 mm3.
Patients with cutaneous infections or anatomical malformation of the spine.
Patients not willing to participate in the study |
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Duration of analgesia |
pain score by FLACC score for every 15minutes in the first hour and every 30minutes for next hour |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of motor blockade between 0.25%bupivacaine and 0.25%levobupivacaine |
duration of motor blockade by MODIFIED BROMAGE SCALE for every 15minutes in the first hour and every 30minutes for next hour |
| To compare the hemodynamic parameters between 0.25%bupivacaine and 0.25% levobupivacaine |
Pulse rate,Blood pressure and oxygen saturation from baseline to every 3minutes for 15minutes and every 5minutes for 30minutes and every 30 minutes fot 120 minutes |
| To compare the incidence of adverse effects between 0.25%bupivacaine and 0.25% levobupivacaine |
Number of adverse effects in the perioperative period |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In Anaesthesia, provision of pain relief is an essential part. One of the most popular regional blocks in children with higher success rate is caudal block for surgeries below the level of umbilicus. It is a useful adjunct technique during general anesthesia and for providing post of analgesia for infra umbilical operations. This technique is easier to perform and reduces the requirement of inhaled and intravenous anesthetic agent. It also attenuates the stress response to surgery, facilitates rapid and smooth recovery and provides reliable analgesia in the immediate post operative period. The quality and level of caudal block is dependent on the dose, volume and concentration of the drug injected. Bupivacaine is long-acting amide local anesthetic that has provided reliable anesthesia and analgesia with differential motor sensory blockade for more than 40years. Cardio toxicity and incidents of prolonged motor blockade urged the need for the development of a drug with wider margin of safety and similar clinical efficacy. So, S-enantiomers of bupivacaine were isolated and synthesized. One of the pure S-enantiomer of bupivacaine is levobupivacaine. It is claimed to have a wider margin of safety like less cardio toxicity and less post operative motor blockade. |