| CTRI Number |
CTRI/2025/11/097544 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Pain Relief Techniques After Kidney Stone Surgery (PCNL): A Study of Nerve Block vs Local Infiltration |
|
Scientific Title of Study
|
Comparison of ultrasound guided single level paravertebral block with peritubal infiltration for postoperative analgesia in patients undergoing 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 |
Dr Kartik |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr. RML HOSPITAL |
| Address |
Room No. 301, PGIMER Building, ABVIMS and DR. RML Hospital, Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
North West
DELHI
110001
India |
| Phone |
9416386867 |
| Fax |
|
| Email |
kartik31singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS and DR. RML HOSPITAL |
| Address |
Room No. 301, PGIMER Building, ABVIMS and DR. RML Hospital, Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS and DR. RML HOSPITAL |
| Address |
Room No. 301, PGIMER Building, ABVIMS and DR. RML Hospital, Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and DR RML HOSPITAL,Baba Kharak Singh Marg, Cannaught Place
Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and DR RML HOSPITAL |
| Address |
Baba Kharak Singh Marg, Cannaught Place
Delhi - 110001 |
| 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 Kartik |
ABVIMS and DR RML HOSPITAL |
Room no 301, Department of Anaesthesia
New Delhi
DELHI |
9416386867
kartik31singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, ABVIMS and Dr RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Peritubal infiltration |
In the comparator group, patients will receive peritubal infiltration of local anesthetic for postoperative analgesia. After completion of the PCNL procedure and placement of the nephrostomy tube, a 22G echogenic needle will be introduced under fluoroscopy guidance along the nephrostomy tract at the 3 o’clock, 6 o’clock, 9 o’clock, and 12 o’clock positions. The needle will be advanced until the renal capsule is contacted, and a total of 20 mL of 0.25% bupivacaine will be administered — 5 mL at each position. The anesthetic will be infiltrated systematically along the renal capsule, muscle, subcutaneous tissue, and skin. |
| Intervention |
Single level paravertebral block |
In the intervention group, patients will receive a single-level thoracic paravertebral block (PVB) for postoperative analgesia. The block will be administered at the T8–T9 paravertebral space under ultrasound guidance. A total of 20 ml of 0.25% bupivacaine will be injected as a single bolus. The block will be performed after the completion of the PCNL procedure but before reversal of general anesthesia. This single-shot regional anesthesia is expected to provide effective postoperative pain relief. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologists class I and class II patients. |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to local anaesthetics.
2. Pregnant patients.
3. Patients with neurological disorders like multiple sclerosis, parkinson’s etc. that may affect pain perception.
4. Patients with psychiatric illnesses that may cause difficulty in pain assessment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total tramadol consumption |
In 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain scores using NRS |
At 0,1,2,4,8, 12 and24 hours post operatively |
| Time for first rescue analgesic request. |
|
| Haemodynamic parameters(heart rate, systolic blood pressure, diastolic, blood pressure, mean arterial pressure) |
At zero, one, two, four, eight, twelve and twenty four hours post operatively |
| Time taken to give two blocks |
|
| Complications of blocks, if any |
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/11/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This randomized comparative study aims to evaluate the postoperative analgesic efficacy of ultrasound-guided single-level thoracic paravertebral block (PVB) versus peritubal infiltration (PTI) in patients undergoing percutaneous nephrolithotomy (PCNL) under general anesthesia. PCNL, although minimally invasive, is often associated with moderate to severe postoperative pain due to renal capsular stretch, pelvicalyceal system distension, and nephrostomy tube irritation. Effective pain control is crucial to enhance recovery and reduce opioid-related side effects.
A total of 30 adult patients (aged 18–65 years) with ASA I–II undergoing elective PCNL will be enrolled and randomized into two equal groups. Group PV will receive a single-level ultrasound-guided PVB at the T8–T9 level with 20 mL of 0.25% bupivacaine. Group PT will receive four-quadrant peritubal infiltration with the same volume and concentration of bupivacaine under fluoroscopic guidance. All patients will receive standard general anesthesia and postoperative monitoring.
The primary outcome is total tramadol consumption in the first 24 hours postoperatively. Secondary outcomes include pain scores using the Numerical Rating Scale (NRS) at multiple time points, time to first rescue analgesia, hemodynamic parameters, block administration time, and any complications.
This study seeks to identify which of the two regional analgesia techniques provides superior pain control with minimal side effects, potentially optimizing postoperative care in PCNL patients.
|