| CTRI Number |
CTRI/2021/08/036068 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
28/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound guided Sacral erector
spinae plane block versus caudal epidural block for lower abdominal and lower limb surgery in children for analgesic efficacy |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block with Caudal Epidural Block using Ultrasound in Children Undergoing Lower Abdominal and Lower Limb Surgery under General Anaesthesia; An Exploratory Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Talawar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
6th floor Medical college building AIIMS Rishikesh
Department of Anaesthesiology 6th floor Medical college building AIIMS Rishikesh
Dehradun
UTTARANCHAL
6th floor Medical college building AIIMS Rishikesh
Department of Anaesthesiology 6th floor Medical college building AIIMS Rishikesh
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
6th floor Medical college building AIIMS Rishikesh
Department of Anaesthesiology 6th floor Medical college building AIIMS Rishikesh
Dehradun
UTTARANCHAL
6th floor Medical college building AIIMS Rishikesh
Department of Anaesthesiology 6th floor Medical college building AIIMS Rishikesh
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
6th floor Medical college building AIIMS Rishikesh
Department of Anaesthesiology 6th floor Medical college building AIIMS Rishikesh
Dehradun
UTTARANCHAL
6th floor Medical college building AIIMS Rishikesh
Department of Anaesthesiology 6th floor Medical college building AIIMS Rishikesh
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh
Veerabhadra road
Shivaji nagar
Uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Praveen Talawar |
AIIMS Rishikesh |
Department of Anaesthesiology
6th level
Medical college building
AIIMS Rishikesh
Dehradun
UTTARANCHAL |
9654162941
praveenrt64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I: Ultrasound Guided Caudal Epidural analgesia
Group-II: Ultrasound Guided Sacral Erector Spinae Plane Block |
both Groups receive- bupivacaine (0.25%) at 1ml/kg volume under ultrasound guidance |
| Comparator Agent |
Ultrasound Guided Caudal Epidural Analgesia Group |
After Induction of anaesthesia and securing airway with supraglottic airway or endotracheal tube, children will be placed in left lateral position to receive caudal epidural analgesia under ultrasound imaging
0.25% bupivacaine, 1ml/kg volume of local anaesthetic will be injected under ultrasound guidance |
| Comparator Agent |
Ultrasound Guided Sacral Erector Spinae Plane Block |
After Induction of general anaesthesia for children, they will be placed in left lateral position to receive ultrasound guided sacral erector spinae plane block
0.25% bupivacaine, 1ml/kg volume of local anaesthetic will be injected |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
•Age 1-9 years
•Both genders
•ASA Physical status I-III |
|
| ExclusionCriteria |
| Details |
• Parent refusal
• Infection at the site of insertion of block.
• Allergic to LA
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia provided by each block technique |
assessed using FLACC Score after 0 1 6 12 18 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Total rescue analgesia required in 24 hrs.
2)Complications related to sacral erector spinae block.
|
assessed after 24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Only Case reports available at the time of ethics committee approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Lower limb and lower abdominal surgeries are done usually under GA in pediatric age group. Caudal analgesia is often supplemented for these surgeries for perioperative pain control. Caudal analgesia though provides excellent pain relief, has limitations of urinary retention, limited duration of analgesia.
Erector spinae plane block is recently described for various surgeries (eg: cervical, thoracic, lumbar and sacral erector spinae plane block) according to desired dermatomes level required. Sacral erector spinae plane block is recently described regional anesthesia technique where local anaesthetic (LA) agent is deposited above the sacral bone and below the erector spinae muscle.
We hypothesize that, sacral erector spinae plane block provides equivalent analgesia as compared to caudal epidural block with a longer duration of analgesia than caudal block as the drug reaches caudal epidural space slowly through posterior sacral foramina.
Present study is planned to know the duration of analgesia provided by sacral erector spinae plane block in comparison with caudal epidural analgesia in children undergoing lower limb and lower abdominal surgeries under GA. |