CTRI Number |
CTRI/2022/08/045033 [Registered on: 29/08/2022] Trial Registered Prospectively |
Last Modified On: |
26/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Erector spinae plane block (block given in the back) for pain relief following kidney stone surgery |
Scientific Title of Study
|
Erector spinae plane block for postoperative analgesia following percutaneous nephrolithotomy: A randomized controlled study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr S Sonika |
Designation |
PG Resident |
Affiliation |
M S Ramaiah Medical College |
Address |
Department of Anaesthesiology
M S Ramaiah Medical College
Bangalore Department of Anaesthesiology
M S Ramaiah Medical College
Bangalore Bangalore KARNATAKA 560054 India |
Phone |
9483392030 |
Fax |
|
Email |
sonika.shivakumar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Tejesh C A |
Designation |
Professor |
Affiliation |
M S Ramaiah Medical College |
Address |
Department of Anaesthesiology
M S Ramaiah Medical College
Bangalore Department of Anaesthesiology
M S Ramaiah Medical College
Bangalore Bangalore KARNATAKA 560054 India |
Phone |
9886481848 |
Fax |
|
Email |
drtejeshca@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Tejesh C A |
Designation |
Professor |
Affiliation |
M S Ramaiah Medical College |
Address |
Department of Anaesthesiology
M S Ramaiah Medical College
Bangalore Department of Anaesthesiology
M S Ramaiah Medical College
Bangalore
KARNATAKA 560054 India |
Phone |
9886481848 |
Fax |
|
Email |
drtejeshca@yahoo.com |
|
Source of Monetary or Material Support
|
M S Ramaiah Medical College
Bangalore |
|
Primary Sponsor
|
Name |
M S Ramaiah Medical College |
Address |
New BEL Road
MSRIT Post
MSR Nagar
Bangalore 560054 |
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 Tejesh C A |
M S Ramaiah Medical College Hospital |
Department of Anaesthesiology
Second Floor
M S Ramaiah Medical College Hospital
New BEL Road
Bangalore 560054 Bangalore KARNATAKA |
9886481848
drtejeshca@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
M S Ramaiah Medical College Ethics Committee |
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 |
Intervention |
Erector spinae plane block with 0.25% Bupivacaine |
Erector spinae plane block will be given under ultrasound guidance with 20mL of 0.25% Bupivacaine on the side of surgery only once after completion of the surgical procedure |
Comparator Agent |
Erector spinae plane block with normal saline |
Erector spinae plane block will be given under ultrasound guidance with 20mL of Normal saline on the side of surgery only once after completion of the surgical procedure |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
American Society of Anaesthesiology physical status 1 and 2
Unilateral Percutaneous Nephrolithotomy Surgery |
|
ExclusionCriteria |
Details |
BMI ≥ 35kg/m2
Bilateral PCNL
Chronic analgesic use
Allergy to local anaesthetics
Contraindications to ESP block
Cognitive dysfunction
Pregnancy
Spine deformity
Relook Percutaneous Nephrolithotomy Surgery |
|
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 |
Total analgesic requirement in the first 24 hours after surgery |
Total analgesic dose consumed will be assessed at the end of 24 hours after surgery. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time to first demand of rescue analgesia
|
Pain assessed at intervals of 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery |
Postoperative pain |
Pain assessed at intervals of 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery |
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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
|
N/A |
Date of First Enrollment (India)
|
01/09/2022 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
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 - 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sonika.shivakumar@gmail.com].
- For how long will this data be available start date provided 22-04-2024 and end date provided 22-04-2029?
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
|
Percutaneous nephrolithotomy (PCNL) is currently the
frequently employed surgical procedure for the removal of large complex renal
and proximal ureteric calculi. Being minimally invasive it has
less morbidity, and allows early recovery and ambulation after surgery. Postoperative
pain following PCNL has both visceral and somatic components. Visceral
component arises from the kidney, renal capsule and ureter, while the somatic
component from the skin incision and the nephrostomy tract. The nephrostomy tube that is inserted at the end of the procedure can elicit
inflammatory reaction leading to pain and discomfort.
Although PCNL is a minimally invasive procedure,
postoperative pain can be severe and inadequate postoperative analgesia is a
barrier to early recovery after surgery. Systemic analgesics like opioids,
non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol form the
mainstay for providing pain relief. However, opioids are associated with side
effects like nausea, vomiting, pruritus, constipation, and respiratory
depression, while NSAIDs may be relatively contraindicated in these patients
who may have compromised renal function.
Regional anaesthetic techniques like intercostal
nerve block, paravertebral block, epidural analgesia, peritubal infiltration
and subcutaneous infiltration have been employed for providing postoperative
analgesia following PCNL.Erector spinae plane [ESP] block is a
recently described interfascial plane
block for providing postoperative analgesia following thoracic and abdominal
surgeries.Its use for providing pain relief following PCNL is
recently been described in literature, However , there is paucity
of literature providing its efficacy following PCNL surgery. Hence, the present
study is designed to evaluate its role in providing postoperative analgesia
following PCNL. |