| CTRI Number |
CTRI/2022/09/045987 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF TWO REGIONAL BLOCKS FOR PAIN RELIEF IN CHILDREN UNDERGOING OPEN PYELOPLASTY. |
|
Scientific Title of Study
|
EFFICACY OF ERECTOR SPINAE PLANE BLOCK VS CAUDAL EPIDURAL BLOCK FOR PERIOPERATIVE ANALGESIA IN CHILDREN UNDERGOING OPEN PYELOPLASTY: A RANDOMIZED CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEEPANJALI PANT |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SIR GANGA RAM HOSPITAL |
| Address |
SIR GANGA RAM HOSPITAL SIR GANGA RAM HOSPITAL MARG OLD RAJINDER NAGAR NEW DELHI 110060
Central
DELHI
110060
India |
| Phone |
9818271871 |
| Fax |
|
| Email |
deepanjalipant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPANJALI PANT |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SIR GANGA RAM HOSPITAL |
| Address |
SIR GANGA RAM HOSPITAL SIR GANGA RAM HOSPITAL MARG OLD RAJINDER NAGAR NEW DELHI 110060
Central
DELHI
110060
India |
| Phone |
9818271871 |
| Fax |
|
| Email |
deepanjalipant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SREETAMA SANYAL |
| Designation |
DNB RESIDENT |
| Affiliation |
SIR GANGA RAM HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SIR GANGA RAM HOSPITAL SIR GANGA RAM HOSPITAL MARG OLD RAJINDER NAGAR NEW DELHI 110060
Central
DELHI
110060
India |
| Phone |
9051308756 |
| Fax |
|
| Email |
sanyalsreetama@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF ANAESTHESIOLOGY
SIR GANGA RAM HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SIR GANGA RAM HOSPITAL |
| Address |
SIR GANGA RAM HOSPITAL, SIR GANGA RAM HOSPITAL MARG, OLD RAJINDER NAGAR, NEW DELHI 110060 |
| 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 DEEPANJALI PANT |
SIR GANGA RAM HOSPITAL |
OT NUMBER 22, DEPARTMENT OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDICINE, SIR GANGA RAM HOSPITAL, SIR GANGA RAM HOSPITAL MARG, OLD RAJINDER NAGAR, NEW DELHI 110060
Central
DELHI |
9818271871
deepanjalipant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, SIR GANGA RAM HOSPITAL |
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 |
CAUDAL EPIDURAL BLOCK |
The caudal epidural block is performed in the left lateral decubitus position by identifying the
sacral hiatus by the landmarks of the sacral cornua found on each side, superior to the gluteal
cleft and at the apex of a triangle formed by the sacral hiatus with the posterior superior iliac
spines. |
| Intervention |
ERECTOR SPINAE PLANE BLOCK |
It is a form of regional anaesthesia performed at the level of T9-10 with the patient in lateral decubitus
position with operated site up. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Open pyeloplasty
2. Children between 2 months to 7 years of age.
3. ASA grade I and II |
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity to ropivacaine and clonidine
2. Spine or chest wall deformity
3. Impaired cardiac, hepatic or neurological function
4. Patients with coagulative disorders
5. Parents unwilling to participate
6. Developmental delay
7. Undergoing additional surgical procedure at an anatomical location not covered by unilateral ESPB. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perioperative fentanyl usage (Intraoperative and postoperative fentanyl usage will be
measured.) |
Perioperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to first rescue analgesia in Post Anaesthesia Care Unit
2. Haemodynamic stability by comparing the haemodynamic parameters (heart rate and
mean arterial pressure)
3. Post Operative Side Effects – Sedation, Retching, Vomiting, Motor weakness |
Postoperative period |
|
|
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 |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
With the increasing use of ultrasound guided interventions, the erector spinae plane block (ESPB) is slowly gaining popularity for perioperative analgesia in paediatric surgeries. ESPB is a novel interfascial plane block in which a local anaesthetic agent is injected under USG guidance between the Erector spinae muscle and the underlying vertebral transverse processes. In comparison to the popular central neuraxial caudal epidural block (CEB), the ESPB is superficial, and there are no major neurovascular structures in close vicinity of the fascial plane. Applying the ESPB post induction in a surgery like pyeloplasty under GA will thus reduce the chances of neurovascular injury and also decrease the requirements of systemic and opioid analgesics. This will reduce the incidence of respiratory depression, confusion, nausea, vomiting, drowsiness, and prolonged hospital stay etc. seen with opioid use. The proposed randomized controlled study aims to compare the perioperative analgesic efficacy of ESPB vs. CEB in children with PUJ obstruction undergoing pyeloplasty. The study will be carried out among 60 subjects divided into two groups. FLACC score will be measured postoperatively at subsequent time intervals namely at 0 min, 30 min, 1h, 2 h, 3hr, 6 h, 12 h, 18 h and 24 h. Following induction of anaesthesia, Group ESPB will receive an ultrasound guided erector spinae plane block and Group CEB will receive a caudal epidural block. We hypothesize that administration of an ultrasound guided single shot ESPB post induction in an open pyeloplasty operation will be more efficacious for perioperative analgesia and reduce the need for systemic opioids, as compared to a single shot CEB. |