| CTRI Number |
CTRI/2026/01/101876 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
New spinal anaesthesia technique for the PCNL operation of the kidney stones |
|
Scientific Title of Study
|
A Pilot Study on the Feasibility, Safety, and Analgesic Efficacy of Segmental Spinal Anaesthesia Combined with Quadro-Iliac Plane Block in Percutaneous Nephrolithotomy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SATYADEO SHARMA |
| Designation |
Associate Professor- Urology and Renal Transplant |
| Affiliation |
AIIMS Raipur |
| Address |
Urology OPD, Gate number 4, Ground floor, C-block, All India Institute of Medical Sciences, AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
7772967744 |
| Fax |
|
| Email |
satyadeo2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SATYADEO SHARMA |
| Designation |
Associate Professor- Urology and Renal Transplant |
| Affiliation |
AIIMS Raipur |
| Address |
Urology OPD, Gate number 4, ground floor, C- block, All India Institute of Medical Sciences, AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
7772967744 |
| Fax |
|
| Email |
satyadeo2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SATYADEO SHARMA |
| Designation |
ASSOCIATE PROFESSOR UROLOGY |
| Affiliation |
AIIMS Raipur |
| Address |
Gate number 4, ground floor C block, urology OPD, AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
7772967744 |
| Fax |
|
| Email |
satyadeo2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, AIIMS Raipur, Chhattisgarh, India |
| NIL |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
All India Institute of Medical Sciences, AIIMS RAIPUR, Chhattisgarh, India PIN-492099 |
| Type of Sponsor |
Government medical college |
|
|
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 Satyadeo sharma |
All India Institute of Medical Sciences, Raipur |
Urology department, ground floor, C-block, gate number 4, AIIMS RAIPUR
Raipur
CHHATTISGARH |
7772967744
satyadeo2004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
spinal segmental anaesthesia with quadroilliacplane block in percutaneous nephrolithotomy |
Segmental spinal block with 7.5–10 mg 0.5% bupivacaine + 20 mcg fentanyl
Ultrasound-guided QIP block using 0.25% ropivacaine, 30–40 mL bilaterally
Dermatomal spread assessed via cold swab and pinprick every 5 min until 15 min or max spread
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18–65 years
ASA I–II
Scheduled for elective prone PCNL
|
|
| ExclusionCriteria |
| Details |
Infection at the SSA or QIP site
Coagulopathy, INR more than 1.5, Platelets less than 100000
Mallampati score 3 or more
Opioid use for less than 30 days in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility and Safety of SSA with QIP Block Technique in PCNL |
Feasibility
Successful administration of segmental spinal and QIP block within 1 hour, without conversion to general anesthesia.
Incidence of intraoperative hypotension SBP drop more than 20% from baseline.
Bradycardia HR less than 50 bpm requiring intervention.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pain assessment by the VAS scale
opioid use
time for block onset in minutes |
VAS scores at 0, 2, 6, 12, and 24 hours post-op. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Percutaneous Nephrolithotomy (PCNL) is a minimally invasive surgical procedure used to remove kidney stones. It is typically performed under general anesthesia (GA), which puts the patient to sleep and involves artificial airway support and breathing. While GA is effective, it carries certain risks—especially for patients who are positioned face-down (prone) during surgery. These risks include low blood pressure, breathing problems, and longer recovery times. This study explores an alternative method using regional anesthesia—specifically, a technique called Segmental Spinal Anaesthesia (SSA) combined with a Quadro-Iliac Plane (QIP) block. Instead of putting the patient completely to sleep, these methods numb only the specific areas of the body involved in the surgery. This approach may offer better safety for patients by reducing the risks associated with GA, while still providing effective pain relief. The goal of this pilot study is to assess whether this new anesthesia method is safe, feasible, and effective for PCNL |