| CTRI Number |
CTRI/2023/01/049220 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
16/01/2023 |
| 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
|
Comparative study of patient will recieve retrolaminar block with patient will not receive retrolaminar block in adult patient undergoing percutaneous nephrolithotomy surgery |
|
Scientific Title of Study
|
Comparative study of analgesic effectiveness in Retrolaminar block with intravenous patient controlled analgesia (PCA) in adult patients undergoing percutaneous nephrolithotomy surgery : A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu kumari |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical science patna |
| Address |
Department of Anaesthesiology , All India Institute of Medical Science Patna Phulwari Sharif Patna
Department of Anaesthesiology , All India Institute of Medical Science Patna Phulwari Sharif Patna
Patna
BIHAR
801507
India |
| Phone |
08826027590 |
| Fax |
|
| Email |
ku.anu373@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
poonam kumari |
| Designation |
Associate professor |
| Affiliation |
All india institute of medical science patna |
| Address |
Room no 506
5th floor ot complex ipd building
Aiims patna
Room no 506
5th floor ot complex ipd building
Aiims patna
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu Kumari |
| Designation |
junior resident |
| Affiliation |
All india institute of medical science patna |
| Address |
Department of Anaesthesiology , All India Institute of Medical Science Patna Phulwari Sharif Patna
Department of Anaesthesiology , All India Institute of Medical Science Patna Phulwari Sharif Patna
Patna
BIHAR
801507
India |
| Phone |
8826027590 |
| Fax |
|
| Email |
kuanu373@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical science patna |
|
|
Primary Sponsor
|
| Name |
All india institute of medical science |
| Address |
Urology ot
5th complex ipd building
Aiims patna |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All india institute of medical science |
Urology ot
5th complex ipd building
aiims patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Poonam kumari |
All India Institute Of Medical Sceience Patna |
Department of anaesthesiology Patna BIHAR
Patna
BIHAR |
7992418189
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, (2) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (5) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anesthesia and opioids through PCA fentanyl pump |
PCA fentanyl pump with 0.5mcg/kg at loading dose with lockout interval 15 min for postoperative 24 hours |
| Intervention |
general anesthesia with retrolaminar block |
0.25% bupivacaine of total volume 20 ml while intraoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 70 (Either sex)
ASA I/II
BMI <30kg/m2 |
|
| ExclusionCriteria |
| Details |
History of focal neurological deficit
psychiatric disorder
coagulation disorder
liver pathology
use of any opioid in last 6 month |
|
|
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 measure perioperative fentanyl consumption in 24 hours |
To measure perioperative fentanyl consumption in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of first rescue analgesia
NRS score at post operative period |
NRS score postoperative at 30 min,2 hour,4 hour,8 hour,12 hour,24 hour |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/02/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparative study of analgesic effectiveness in Retrolaminar block with intravenous patient controlled analgesia (PCA) in adult patient undergoing percutaneous nephrolithotomy surgery: A randomized controlled trialINTRODUCTION - Percutaneous nephrolithotomy is a surgical procedure commonly used to treat large kidney stones. It is usually accompanied by severe pain and discomfort postoperatively.
- Regional blocks have been used to control post operative pain are QLB, subcostal block, paravertebral block and erector spinae block.
- Ultrasounded guided retrolaminar block is recently introduced as a regional analgesia technique for surgeries in thoracolumbar region.
AIM :To evaluate the analgesic effect of US guided RLB in terms of reducing the perioperative (24 hours) opioid consumption in patients with PCNL surgery.
OBJECTIVE Primary objective: To measure perioperative total fentanyl consumption in 24 hours. Secondary objective: Time of first rescue analgesia : NRS score postoperative period 30 min,2 hour,4 hour,8 hour,12 hour,24 hour METHODOLGY STUDY DESIGN: double blinded, randomised controlled trial STUDY POPULATION : All patient undergoing PCNL procedure in AIIMS patna SAMPLING TECHNIQUE: Patient will be divided by computer generated randomization number into group I and II Group I: will receive general anesthesia only Group II: will receive general anesthesia and retrolaminar block.
After taking written consent from the study participants and will explain about the procedure technique and education about numerical rating score (NRS) and PCA pump to patient. The patient will be nil per oral for 8 hours prior to procedure. standard monitoring pulse oximetry, non invasive blood pressure and ECG will be attached after entering the operation theatre and baseline value will be noted. All patient in both group will receive general anesthesia. Patient will induced with fentanyl 2 mcg/kg, propofol 2 mg/kg and atracurium 0.5mg/kg. After induction patient will be intubated with endotracheal tube. Anesthesia will be maintained with isoflurane, oxygen and air to maintain minimum alveolar concentration(MAC). After placing the patient to prone position all patients of group II will receive US guided RLB at T9 level. For this we will place a linear US probe longitudinally in midline to identified spinous process of T9 level vertebra. Following this the US probe will be slide slightly laterally toward the operating side to identified following structure the lamina ( horse head sign of hyperechoic structure).erector spinae muscle and the hyperechoic dura between two lamina. The needle will be inserted in plane to the probe in cranial or caudal direction towards the targeted lamina (1 to 1.5 cm lateral to the target spinous process) and needle tip will be contacted with lamina. After negative aspiration for blood and air 0.25% bupivacaine of total volume 20 ml will be injected. patient of group I will not receive any intervention.At the end of surgery total intraoperative fentanyl consumption will be noted in both group. Postoperative all patients will receive paracetamol 1 gm iv every 6 hourly. All patient enrolled in study will be provided with PCA fentanyl pump with 0.5mcg/kg fentanyl at each loading but not infusion. Lockout interval 15 min. The patient will be instructed to use the pump when NRS will be 4 or above. The fentanyl consumption will be recorded during intra and post operative 24 hours by a researcher who is not a member of the surgical team (30 min,2 hours,4 hours,8 hoyrs,12 hours,24 hours). |