| CTRI Number |
CTRI/2025/11/096923 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study to compare erector spinae plane block and retrolaminar block for postoperative analgesia after percutaneous nephrolithotomy. |
|
Scientific Title of Study
|
Comparison of erector spinae plane block versus retrolaminar block using ultrasonography 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 |
Varada Krishnan K |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology
Sapthagiri Institute of Medical Sciences and Research Centre
Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
8304022356 |
| Fax |
|
| Email |
Varadakkrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikila D G |
| Designation |
Associate Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology
Sapthagiri Institute of Medical Sciences and Research Centre
Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9535243669 |
| Fax |
|
| Email |
nikiladg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikila D G |
| Designation |
Associate Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology
Sapthagiri Institute of Medical Sciences and Research Centre
Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9535243669 |
| Fax |
|
| Email |
nikiladg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre, Chikkabanavara, Hesarghatta Main road, Bangalore,Karnataka
India
560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology
Sapthagiri Institute of Medical Sciences and Research Centre
Bangalore, Karnataka, India
560090 |
| Type of Sponsor |
Private 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 |
| Varada Krishnan K |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology, Ground floor,Chikkabanavara, Hesarghatta Main road, Bangalore, Karnataka, India 560090
Bangalore
KARNATAKA |
8304022356
Varadakkrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
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: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound-Guided Erector Spinae Plane Block |
A linear probe will be placed on transverse orientation in midline, T10 identified,probe is moved laterally till transverse process on surgical side, rotated 90degree, landmarks identified, under aseptic precautions using 22Guage spinal needle in line, 0.25 percent Inj. Bupivacaine 20 milli litres injected between transverse process and Erector spinae muscle. Numerical rating scale is assessed in both the group at 30 minutes, 1 hour, hourly for 6 hours and 4 hourly for 24 hours. |
| Intervention |
Ultrasound-Guided Retrolaminar Block |
A linear ultrasound probe will be placed sagitally on the surgical side, afteridentifying the spinous process , the ultrasound probe is moved laterally 1-2cm and vertebral laminae will be observed. A 22Guage needle will be inserted from cranial to caudal direction with in plane technique. When needle touches lamina, and location is confirmed 20 millilitre 0.25 percent Inj. Bupivacaine will be administered with low pressure. Numerical rating scale is assessed in both the group at 30 minutes, 1 hour, hourly for 6 hours and 4 hourly for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders belonging to American Society of Anesthesiologists physical status I and II between 18 to 65 years, posted for unilateral percutaneous nephrolithotomy under general anaesthesia from whom written and informed consent is taken. |
|
| ExclusionCriteria |
| Details |
Contraindicatios to peripheral nerve blocks, Sepsis or bacteremia, Allergic to the drug used, Patients with spine abnormalites, pregnant and lactating patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is undertaken to determine the efficacy of ultrasound guided erctor spinae plane block versus retrolaminar block for post operative pain management in patients undergoing percuaneous nephrolithotomy |
NRS is assessed in both the group at 30 minutes, 1 hour, hourly for 6 hours and 4 hourly for 24 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="6"
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
|
Renal stones are a significant medical issue and percutaneous nephrolithotomy is the generally considered treatment for large or staghorn calculi. Even though it’s a minimally invasive endourological procedure, PCNL is associated with severe visceral and somatic pain which is attributed to various factors, including surgical incision, renal parenchymal injury, renal capsule stretch and nephrostomy tube insertion. Post operative pain is a complex condition that needs a multimodal approach and good pain management which can decrease hospital stay, rate of complications and decrease overall health cost. Thus, the Multimodal postoperative pain management approach helps in reducing opioid related side effects early recovery and helps to shorten the duration of hospital stay. While appropriate post operative analgesic management in these patients involve various techniques such as intravenous systemic analgesics, regional techniques such as Epidural analgesia, Paravertebral Block and Quadratus lumborum Block and local anesthetic infiltrations, these systemic analgesics have found to have few side effects and various regional techniques are found to be invasive. Hence the interfascial plane blocks such as Erector Spinae Plane Block, Retrolaminar Block, Transverse abdominis plane block are found to be the safer alternatives and less invasive. Erector Spinae Plane Block is a newer approach of paraspinal fascial plane block which was first described by Forero et al., in 2016 in which local anesthetic is injected deep to the erector spinae muscle and superficial to the transverse process, to attain block in the dorsal and ventral rami of spinal nerves. This provides multilevel analgesia, is simple and safe far from pleura, major vessels, neuraxis and can be given bilaterally. Whereas Retrolaminar Block is a modified paravertebral technique with a local anesthetic injected at the vertebral lamina, deep to the erector spinae muscles but closer to the lamina. It is an easier technique than the ultrasound-guided paravertebral block that is technically challenging and time consuming. It is far from pleura and neuraxis and hence found to have minimal risk of pneumothorax. With this background, the present study is undertaken to determine and compare the efficacy of ultrasound guided Erector Spinae Plane Block versus Retrolaminar Block for postoperative pain management in patients undergoing PCNL. |