| CTRI Number |
CTRI/2020/12/029732 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
10/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Paraspinal blocks for complete surgical anesthesia for percutaneous nephrolithotomy |
|
Scientific Title of Study
|
Ultrasound guided paraspinal blocks for complete surgical anesthesia for percutaneous nephrolithotomy – A prospective randomized pilot study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh J Prajapati |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Deparment of Anesthesia
Dr Virendra Desai Road
Kheda
GUJARAT
387001
India |
| Phone |
09879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh J Prajapati |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Department of Anesthesia
Dr Virendra Desai Road
Kheda
GUJARAT
387001
India |
| Phone |
09879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh J Prajapati |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Department of anesthesia
Dr Virendra Desai Road
Kheda
GUJARAT
387001
India |
| Phone |
09879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Muljibhai Patel Urological Hospital, Dr Virendra Desai Road, Nadiad-387001 |
|
|
Primary Sponsor
|
| Name |
Muljibhai Patel Urological Hospital Nadiad |
| Address |
Dr Virendra Desai Road, Nadiad |
| 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 Shailesh Soni |
Muljibhai Patel Urological Hospital |
Department on Anesthesiology, Dr Virendra Desai Road,
Nadiad-387001
Kheda
GUJARAT |
02682520323
sonishail@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group E |
Received Rupivacaine 0.5% 20 ml in erector spinae block at the level of T11 vertebra |
| Intervention |
Group P |
Received Rupivacaine 0.5% 20 ml in paravertebral block at the level of T11 vertebra |
| Intervention |
Group PE |
Received Rupivacaine 0.5% 15 ml at the level of T11 vertebra for Paravertebral block and received mixture of Rupivacaine 0.325% 15ml ml at the level of T11 vertebra for erector spinae block. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with American Society of Anesthesiologists (ASA) physical status classes I or II,
2.Scheduled for all unilateral PCNL, Mini PCNL and Tubeless PCNL. |
|
| ExclusionCriteria |
| Details |
1.Psychological disorders,
2.BMI>25, hepatic or renal dysfunction,
3.Coagulation disorders,
4.Sepsis, history of chronic analgesic use
5.History of allergy to local anesthetic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the feasibility of paraspinal blocks (PVB, ESPB and combined PVB and ESPB) as complete surgical anesthesia for PCNL. |
24 hours after Procedure postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the onset of effect of paraspinal block
2.To compare perioperative heamodynamic stability
3.To compare the need of additional sedation, deep sedation or GA
4.To compare duration of analgesia (Time to first analgesia) and total analgesia requirement in 24 hours.
|
24 hours after procedure postoperatively |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2021 |
| 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
|
1 Solakhan M, Bulut E, Erturhan MS. Comparison of Two Different Anesthesia Methods in Patients Undergoing Percutaneous Nephrolithotomy. Urol J. 2019;16(3):246-50.
2. Liu Y, Yu X, Sun X, Ling Q, Wang S, Liu J, et al. Paravertebral block for surgical anesthesia of percutaneous nephrolithotomy: Care-compliant 3 case reports. Medicine (Baltimore). 2016;95(28):e4156.
3. Ahmed DG HD, Abdelraouf AMS Percutaneous Nephrolithotomy under Thoracic Paravertebral Block: A Preliminary Report. J Anesth Clin Res. 2017;8(4):720.
4. Li C, Song C, Wang W, Song C, Kong X. Thoracic Paravertebral Block versus Epidural Anesthesia Combined with Moderate Sedation for Percutaneous Nephrolithotomy. Med Princ Pract. 2016;25(5):417-22.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PCNL has been performed under general anesthesia(GA) , Regional anesthesia(RA) , PVB and LA. GA and RA (including spinal, epidural and combined spinal-epidural anesthesia) were commonly used for PCNL. In the prevailing COVID-19 scenario, the regional anaesthesia is preferred over general anaesthesia to reduce the risk of transmission in suspected or confirmed case of COVID-19. Paravertebral block (PVB) is the technique of injecting a local anesthetic agent adjacent into the vertebra close to where the spinal nerves exit the intervertebral foramina. It leads to blockade of ipsilateral, segmental, somatic, and sympathetic nerve. Erector spinae plane block (ESPB) is a novel paraspinal fascial plane block in which local anesthetics injected between erector spinae and thoracic transverse process resulting in blockage of the dorsal and ventral rami of the thoracic and abdominal spinal nerves. Ultrasound guided paraspinal blocks allow to reduce the incidence of failure rate and complications (likes, pneumothorax and vascular puncture) as well as also help in local anaesthesitc dosages. There was no study reported for comparison of PVB, ESPB and combined blocks for PCNL as a complete surgical anaesthesia. Our aim of the study to provide alternative regional anesthesia technique for PCNL under ultrasound guided paraspinal blocks with conscious sedation.
|