| CTRI Number |
CTRI/2023/07/054748 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between spinal anaesthesia and caudal anaesthesia in children undergoing surgeries below umbilicus |
|
Scientific Title of Study
|
Comparative study of spinal anaesthesia versus caudal anaesthesia in paediatric patients undergoing infraumbilical surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keerthana S |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Anaesthesia department
2nd floor
Dr susheela Tiwari hospital
Government Medical College,
Haldwani,
Nainital
Uttarakhand 263139
Nainital
UTTARANCHAL
263139
India |
| Phone |
8722686989 |
| Fax |
|
| Email |
keerthanareddy96.kr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Bhandari |
| Designation |
Professor and HOD, Department of anaesthesiology |
| Affiliation |
Government Medical college, Haldwani |
| Address |
Department of anaesthesiology, Government Medical college, Haldwani
Department of anaesthesiology, Government Medical college, Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Bhandari |
| Designation |
Professor and HOD, Department of anaesthesiology |
| Affiliation |
Government Medical college, Haldwani |
| Address |
Department of anaesthesiology, Government Medical college, Haldwani
Department of anaesthesiology, Government Medical college, Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Keerthana S
Department of anaesthesia
2nd floor
Dr. Susheela Tiwari Government Hospital,
Haldwani
Uttarakhand ,263139 |
|
|
Primary Sponsor
|
| Name |
Dr. Keerthana S |
| Address |
Department of Anaesthesiology, Dr Susheela Tiwari government hospital, Rampur road, Haldwani Uttarakhand 263139 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Keerthana S |
Dr Suheela Tiwari Hospital |
Department of Anaesthesiology, 2nd floor,Dr. Suheela Tiwari Hospital, Rampur Road, Haldwani
Nainital
UTTARANCHAL |
8722686989
keerthanareddy96.kr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, GMC, Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Q552||Other and unspecified congenital malformations of testis and scrotum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
caudal anaesthesia |
The study population is divided into two groups of 36 each. Group S undergoing Spinal block and Group C undergoing Caudal block. Group C patients will be given caudal block with full aseptic precautions in left lateral position. Drug-0.5% plain bupivacaine 2mg/kg (1ml/kg according to modified Armitage formula) will be given.
The level of sensory blockade, Heart rate and MAP will be recorded preoperatively and at 5 minutes intervals intraoperatively, and after completion of the surgery. Surgical pain is evaluated through CHIPPS. It would take a total duration of 3-4 hours.. |
| Comparator Agent |
Spinal anaesthesia |
The study population is divided into two groups of 36 each. Group S undergoing Spinal block and Group C undergoing Caudal block. Group S patients receives spinal anaesthesia via midline approach with patients in lateral position under aseptic precautions. After getting free flow of CSF hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg will be injected in the subarachnoid space.
The level of sensory blockade, Heart rate and MAP will be recorded preoperatively and at 5 minutes intervals intraoperatively, and after completion of the surgery. Surgical pain is evaluated through CHIPPS.It would take a total duration of 3-4 hours. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of Anesthesiologist grade I
2. Pediatric cases scheduled for infraumbilical surgeries under spinal or caudal anaesthesia
3. Ages 2 to 10 years |
|
| ExclusionCriteria |
| Details |
1. Parent refusal
2. Infection at the site of injection
3. Coagulopathy
4. Increased intra-cranial pressure
5. Allergy to local anesthetics
6. Spinal deformities such as spina bifida and myelomeningocele
7. Sever aortic and mitral stenosis
8. Shock (haemorrhagic, septic) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the proportion of paediatric patients undergoing infraumbilical surgery in the Caudal & spinal anaesthesia groups who will achieve sensory blockade up to T6 level. |
Till 60 mins post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare Hemodynamics in both the techniques
2. To compare post-operative analgesia in both the techniques
3. To compare parent & surgeon satisfaction in both the techniques |
Till 60 mins post operatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
14/07/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in pediatric patients satisfying all inclusion and exclusion Criteria planned for infraumbilical surgeries. Material used were Quincke type spinal needle of appropriate gauge, Sterile 2 cc and 5 ce syringes. Bupivacaine 0.5% Heavy ampoule, Bupivacaine 0.5% vial, Emergency drugs, IV Fluids, Anaesthesia workstation, suction apparatus Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient.
The study population is divided into two groups of 18 each. Group S undergoing Spinal block and Group C undergoing Caudal block. Group S patients receives spinal anaesthesia via midline approach with patients in lateral position under aseptic precautions. After getting free flow of CSF hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg will be injected in the subarachnoid space. Group C patients I will be given caudal block with full aseptic precautions in left lateral position. Drug-0.5% plain bupivacaine 2mg/kg (1ml/kg according to modified Armitage formula) will be given.
The level of sensory blockade, Heart rate and MAP will be recorded preoperatively and at 5 minutes intervals intraoperatively, and after completion of the surgery. Surgical pain is evaluated through children and infant postoperative pain scale (CHIPPS). |