| CTRI Number |
CTRI/2023/06/053543 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
04/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess pain reducing efficacy of Ultrasound guided Erector Spinae Block versus Quadratus Lumborum III Block in patients undergoing Unilateral Percutaneous Nephrolithotomy Surgery under General Anesthesia
|
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Scientific Title of Study
|
Analgesic Efficacy of Erector Spinae Block versus Quadratus Lumborum III Block in patients undergoing Unilateral Percutaneous Nephrolithotomy Surgery under General Anesthesia
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yamini Arora |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
PG Resident, Department of Anaesthesiology and Critical care AIIMS BHOPAL, Bhopal, Madhya pradesh,462020,India
Bhopal
MADHYA PRADESH
462024
India |
| Phone |
9463458927 |
| Fax |
|
| Email |
YAMINIA.jr2022@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yamini Arora |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
PG Resident, Department of Anaesthesiology and Critical care AIIMS BHOPAL, Bhopal, Madhya pradesh,462020,India
Bhopal
MADHYA PRADESH
462024
India |
| Phone |
9463458927 |
| Fax |
|
| Email |
YAMINIA.jr2022@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Singh |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care AIIMS BHOPAL, Bhopal, Madhya pradesh,462020,India
Bhopal
MADHYA PRADESH
462024
India |
| Phone |
|
| Fax |
|
| Email |
Pooja.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences(AIIMS)Saket Nagar ,Bhopal ,462024, Madhya pradesh , India |
|
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Primary Sponsor
|
| Name |
Dr Pooja Singh |
| Address |
Associate Professor, Department of Anaesthesiology and Critical Care AIIMS BHOPAL, Bhopal. |
| 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 |
| Dr Yamini Arora |
AIIMS BHOPAL |
Department of Anaesthesiology and Critical care AIIMS BHOPAL, Bhopal, Madhya pradesh,India
Bhopal
MADHYA PRADESH |
9463458927
YAMINIA.jr2022@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC PGR |
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: N202||Calculus of kidney with calculus of ureter, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr.Pooja Singh |
Associate professor, Department of Anaesthesiology, AlIMS Bhopal, 462024,Madhya pradesh India |
| Comparator Agent |
Dr.Yamini Arora |
Post graduate Resident, Department of Anaesthesiology, AlIMS Bhopal, 462024,Madhya pradesh India |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Study will include patients between 18 to 65years of either sex with ASA physical status 1 to 3 planned for elective percutaneous nephrolithotomy |
|
| ExclusionCriteria |
| Details |
Patient’s refusal to the procedure.
Contraindications to regional technique e.g., allergy to local anesthetic drugs, infection around site of block, any coagulation disorder, sepsis
Body mass index > 35kg/m2
Pregnancy
Physical or mental disorders that would interfere with evaluation of pain. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare postoperative pain relief using the numeric rating scale (NRS) score between the group E and group Q |
At 1 hour, 2 hours, 6 hours, 12 hours and 24 hours postoperatively at rest and during activity |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine & compare the time of the first analgesic.
2.To determine and compare the total perioperative opioid consumption in 24 hours
3.To determine and compare the rate of complications, time of ambulation and length of hospital stay.
(.between the group E and Q) |
From arrival in postoperative recovery room upto discharge from hospital . |
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
15/06/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published as below |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study to be conducted on total of 78 patients of age between 18 to 65 years of either sex belonging to ASA grade I,II and III undergoing elective unilateral percutaneous nephrolithotomy surgery under general anaesthesia in All India Institute of Medical Sciences, Bhopal after undergoing routine investigations and pre anesthetic check up .An informed written consent will be obtained from patient and legally acceptable witness.Patient will be randomly allocated to either group E, receiving Erector spinae plane block :ESPB or group Q receiving quadratus lumbarm block III :QLB III through computer based allocater . In operation theatre all standard ASA monitoring will be attached and baseline vitals will be recorded including blood pressure ,ECG ,SpO2 , temperature. After induction of general anaesthesia and securing airway ,patient will be positioned according to block i .e. lateral position for QLB III and prone position for ESPB . Block will be performed after satisfactory placement of needle under ultrasound guidance and confirming by injecting 1- 2 ml of saline ,once confirmed 20 ml of inj. BUPIVACAINE 0.25% will be injected. Intraoperative hemodynamic monitoring will be done and Inj FENTANYL 1-2 mcg/kg will be given if heart rate or blood pressure or both increases more than 20% of baseline. After the completion of surgery ,complete recovery from nesthesia and achieving adequate level of consciousness patient will be shifted to postoperative recovery room. Hemodynamic parameters will be monitored for 1 hour and patient will be shifted to ward .NRS scores will be assessed at interval of 1,2,6, 12 and 24 hours postoperative at rest and during activity. If NRS score is >= 3 injection paracetamol 1 gram will be given as rescue drug. If pain persists then injection tramadol 50 mg slow i.v. infusion will be given as second analgesia . NRS scores will be furthers according to timeline and total total dose of tramadol is calculated over 24 hours.Post operative complications will also be monitored. |