| CTRI Number |
CTRI/2025/09/095301 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing retrolaminar vs paravertebral block post operative pain relief in percutaneous nephrolithotomy surgery patients |
|
Scientific Title of Study
|
Efficacy of retrolaminar and paravertebral block for postoperative analgesia in percutaneous nephrolithotomy patients - A double-blinded 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 |
Dharshini K |
| Designation |
PG student |
| Affiliation |
Sri Manakula Vinayagar medical College and Hospital |
| Address |
Room no 2 , 1st floor , Department of anesthesiology , Manakula vinayagar medical college and hospital , Kalitheerthalkuppam, Madagadipet , Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9150234480 |
| Fax |
|
| Email |
dharshini.dharshu.1920@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Dilipchander |
| Designation |
Professor , Department of Anaesthesiology |
| Affiliation |
Sri Manakula Vinayagar medical College and Hospital |
| Address |
Room no 3 , 1st floor , OT block , Department of Anaesthesiology , Sri manakula vinayagar medical college and hospital , Kalitheerthalkuppam , madagadipet , Puducherry
Department of Anesthesiology, First floor, OT Block,
Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Madagadipet, Puducherry- 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchander2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharshini K |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar medical College and Hospital |
| Address |
Room no 2 , 1st floor , OT block , Department of Anaesthesiology , Sri manakula vinayagar medical college , Kalitheerthalkuppam , Madagadipet , Puducherry
Department of Anesthesiology, First floor, OT Block,
Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Madagadipet, Puducherry- 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9150234480 |
| Fax |
|
| Email |
dharshini.dharshu.1920@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula vinayagar Medical college and hospital , Kalitheerthalkuppam , Madagadipet , Puducherry , 605017 |
|
|
Primary Sponsor
|
| Name |
Dharshini K |
| Address |
Department of Anesthesiology, First floor, OT block, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Madagadipet, Puducherry- 605107 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrDharshini |
Sri Manakula Vinayagar Medical College |
Room no 2, I floor, Clinical division, Department of Anesthesiology, Sri Manakula vinayagar medical college ,Kalitheerthalkuppam, Madagadipet, Puducherry- 605107
Pondicherry
PONDICHERRY |
9150234480
dharshini.dharshu.1920@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (2) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paravertebral block |
Paravertebral space is identified. Under aseptic precautions, 23g spinal needle will be advanced to pierce the superior costotransverse ligament just superficial to the pleura. correct plane identified and 20mlof 0.25%bupivacaine is injected. |
| Intervention |
Retrolaminar block |
Retrolaminar block is given at level of T10. the spinous process and adjacent lamina of target thoracic vertebra is identified. Under strict aseptic precautions , 23 G needle is advanced and correct plane identified. 20ml of 0.25%bupivacaine us injected |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS I, II and III
2. Patient posted for elective PCNL |
|
| ExclusionCriteria |
| Details |
patient not giving consent
obesity
allergy to drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative anlagesia provided by retrolaminar block verus paravertebral block in patients undergoing percutaneous nephrolithotomy |
first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain scores |
postoperative period first 24 hours |
| Total rescue analgesic consumption |
postoperative period first 24 hours |
| Block related complications |
postoperative period first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
15/10/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dharshini.dharshu.1920@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This double blinded randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound guided retrolaminar block and paravertebral block in patients undergoing percutaneous nephrolithotomy under spinal anesthesia. After detailed preanesthetic evaluation, patients will be randomized into two groups: Group A - receiving RLB at the T10 level and Group B- receieving PVB at the T10 level , each with 20ml of 0.25% bupivacaine following saline confirmation of needle placement . All patients will receive standard anesthesia. Postoperatively, pain will be asssessed using the Visual Analog scala (VAS) at regular intervals over 24 hours by an independent blinded observer. The primary outcome is the duration of postoperative analgesia, defined as the time to first rescue anlagesia, while secondary outcomes include pain scores, total rescue analgesia consumption, and block related complications. |