| CTRI Number |
CTRI/2025/04/084029 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ultrasound guided block and local site infiltration for post operative analgesia in patients undergoing percutaneous nephrolithotomy. |
|
Scientific Title of Study
|
Comparison of ultrasound guided erector spinae plane block and local infiltration of incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy - Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samruddhi Homkar |
| Designation |
Junior resident |
| Affiliation |
NKPSIMS and Lata Mangeshkar Hospital, Nagpur |
| Address |
Department of Anesthesiology, NKPSIMS and Lata Mangeshkar Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9096061822 |
| Fax |
|
| Email |
samruddhi.jagdish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Bhargava |
| Designation |
Associate Professor |
| Affiliation |
NKPSIMS and Lata Mangeshkar Hospital, Nagpur |
| Address |
Department of Anesthesiology, NKPSIMS and Lata Mangeshkar Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7709428071 |
| Fax |
|
| Email |
bhargavasumita@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Samruddhi Homkar |
| Designation |
Junior resident |
| Affiliation |
NKPSIMS and Lata Mangeshkar Hospital, Nagpur |
| Address |
Department of Anesthesiology, NKPSIMS and Lata Mangeshkar Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9096061822 |
| Fax |
|
| Email |
samruddhi.jagdish@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur 440019. |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Nagpur |
| Address |
NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur 440019. |
| 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 |
| Dr Samruddhi Homkar |
NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital. |
Department of Anesthesiology, Fourth floor, NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur 440019.
Nagpur
MAHARASHTRA |
9096061822
samruddhi.jagdish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block |
Ultrasound guided Erector Spinae Plane block using 20 ml of 0.25% Bupivacaine |
| Comparator Agent |
Local Anesthetic Infiltration |
Local Anesthetic Infiltration at surgical site using 20 ml of 0.25% Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing PCNL surgery under general anesthesia.
Patients satisfying American Society of Anesthesiologists Class 1 and 2.
Patients with BMI less than 35. |
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent.
Patients with spinal deformity. Eg: Kyphoscoliosis
Patients with sensitivity to local anesthetics.
Contraindications to peripheral nerve blocks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Ultrasound guided Erector Spinae Plane Block and local anesthetic infiltration of the incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy |
Numeric Rating Scale.
Time of first rescue analgesia.
Total number of rescue analgesics required in 24 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Ultrasound guided Erector Spinae Plane Block and local anesthetic infiltration of the incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy in terms of occurrence of any postoperative complications |
Nausea
Vomiting
Difficulty in breathing
|
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="0"
Months="4"
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 - NO
|
|
Brief Summary
|
Percutaneous
Nephrolithotomy (PCNL) is a minimally invasive surgical technique used to
remove renal stones which are either difficult to reach or large or numerous or
too dense to be removed by any other method.
It
offers less morbidity, shorter hospital stays and early recovery after surgery.
Pain
after PCNL is caused by dilatation of the renal capsule and the parenchymal
tract and from incision of the skin, subcutaneous tissue, muscle layer and the
presence of nephrostomy tube. Intense
post operative pain also relates to postoperative complications
including pulmonary dysfunction. NSAIDS can cause severe side
effects in these patients with pre existing kidney disease. Therefore they
are not preferred. Loco-regional pain management
techniques available for postoperative analgesia provides good pain
control. Post operative analgesia can also be
provided by opioids. However, opioids have certain side effects such as
nausea, vomiting, itching, respiratory depression etc. Other regional techniques such as
subcutaneous infiltration, peri tubal infiltration, nephrostomy tract
infiltration can be invasive.
Local anesthetic infiltration at the site
of incision does not provide adequate analgesia thereby increasing the duration
of hospital stay. Erector spinae plane block(ESPB) is
a novel technique that is being used nowadays for providing
postoperative analgesia in patients undergoing Percutaneous
Nephrolithotomy (PCNL) surgery. It
is a paraspinal fascial plane block in which the needle placement is between
the erector spinae muscle and the thoracic transverse processes at the level of
T10, and a local anesthetic is administered, blocking the dorsal and ventral
rami of the thoracic and abdominal spinal nerves. This
blockage of the dorsal and ventral rami of the spinal nerves helps to
achieve a multi-dermatomal sensory block of the anterior, posterior, and
lateral thoracic and abdominal walls.
The main sources of acute pain
after PCNL are visceral pain originating from the kidneys and ureters and
somatic pain from the incision site. Renal pain is conducted through
the T10–L1 spinal nerves, and ureter pain is conducted through T10–L2. Moreover, cutaneous innervation of
the incision site is predominantly supplied by T10–T11 (T8–T12)
because the incision site and tract for PCNL is usually used in the
tenth to eleventh intercostal space, or in the subcostal area. There
are limited studies to evidence the benefits of ESPB compared to local
anesthetic with respect to postoperative analgesic effect for patients
undergoing PCNL surgeries. The aim of our study is to evaluate
the efficacy of ESPB compared to local anesthetic for providing
effective postoperative analgesia, requirement of rescue analgesics
as well as to record any complications appearing within 24 hours of
surgery.
|