| CTRI Number |
CTRI/2024/08/073029 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of post operative pain in patients undergoing Percutaneous Nephrolithotomy Surgery |
|
Scientific Title of Study
|
Evaluation of landmark guided erector spinae plane block versus local anaesthetic infiltration of the surgical site for post operative analgesia in patients undergoing Percutaneous Nephrolithotomy surgery: A comparative study |
| 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 Meela Ranjith Kumar |
| Designation |
Junior Resident |
| Affiliation |
Krishna institute of Medical Sciences |
| Address |
Department of Anaesthesia, Krishna Institute of Medical Sciences, NH4, Pune-Bangalore Highway, Agashivnagar, Malkapur, Karad.
Satara
MAHARASHTRA
415539
India |
| Phone |
9132919182 |
| Fax |
|
| Email |
ranjithsdumc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V S Kapurkar |
| Designation |
Associate Professor |
| Affiliation |
Krishna institute of Medical Sciences |
| Address |
Department of Anaesthesia, Krishna Institute of Medical Sciences, NH4, Pune-Bangalore Highway, Agashivnagar, Malkapur, Karad.
Satara
MAHARASHTRA
415539
India |
| Phone |
9881560540 |
| Fax |
|
| Email |
vskapurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V S Kapurkar |
| Designation |
Associate Professor |
| Affiliation |
Krishna institute of Medical Sciences |
| Address |
Department of Anaesthesia, Krishna Institute of Medical Sciences, NH4, Pune-Bangalore Highway, Agashivnagar, Malkapur, Karad.
Satara
MAHARASHTRA
415539
India |
| Phone |
9881560540 |
| Fax |
|
| Email |
vskapurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna institute of Medical Sciences, Krishna Vishwa Vidyapeeth, NH4, Pune - Bangalore Highway, Agashivnagar, Malkapur, Maharashtra, India. PIN: 415539 |
|
|
Primary Sponsor
|
| Name |
Krishna institute of Medical Sciences |
| Address |
NH4, Pune - Bangalore Highway, Agashivnagar, Malkapur, Maharashtra 415539 |
| 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 Meela Ranjith Kumar |
Krishna institute of Medical Sciences |
Department of Anaesthesia, Main OT Complex, Division No 13, First floor, NH4, Pune - Bangalore Highway, Agashivnagar, Malkapur, Karad, PIN: 415539
Satara
MAHARASHTRA |
9132919182
ranjithsdumc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KIMS Deemed to be University, Karad |
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 |
| Intervention |
Inj Ropivacaine 0.75% |
Inj Ropivacaine 0.75% Isobaric 20ml, one time, given as Erector spinae plane block, duration intervention 30min. |
| Intervention |
Inj Ropivacaine 0.75% |
Inj Ropivacaine 0.75% isobaric 20ml, one time, given as local infiltration at the surgical site, duration intervention 10min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with ASA physical status 1 and 2 of either gender.
2. Age 18-65 years.
3. Patients posted for unilateral percutaneous nephrolithotomy surgery under general anesthesia, with endotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
1) Known allergies to the drugs used.
2) Patients using analgesic drugs before surgery or posted for emergency or urgent surgery.
3) Patients with cognitive impairment or mental retardation.
4) Pregnant females.
5) Patients with history of alcohol or drug addiction.
6) Coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time at which the first rescue analgesic dose of Inj. Tramadol 50 mg IV is required by patients with postoperative visual analogue scale (VAS) pain scores of ≥ 4 in the ESPB and LAI groups. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of post-operative nausea and vomiting (PONV) in ESPB & LAI groups within the first 24 hours after surgery |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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 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
|
Background: Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for kidney stones over 2 cm, such as staghorn calculi, particularly when other treatments fail. Despite its advantages, PCNL may cause significant postoperative pain due to renal capsule dilation and nephrostomy tube distension, leading to complications like nausea and vomiting. Effective postoperative analgesia is crucial for enhancing patient recovery, promoting early mobilization, and preventing complications like deep vein thrombosis. Various analgesic strategies, including systemic opioids, NSAIDs, and nerve blocks, have been utilized, but some pose risks.
The erector spinae plane block (ESPB) is a newer method of pain management that involves targeting the erector spinae muscle to anesthetize multiple dermatomes. Although its potential is recognized, research into its effectiveness, particularly in PCNL, remains limited. This study aims to compare the efficacy of ESPB using landmark guidance against local anesthetic infiltration for postoperative analgesia in PCNL, evaluating the timing of the first analgesic dose and overall analgesic consumption in the first 24 hours, alongside monitoring for postoperative nausea and local anesthetic toxicity. Purpose of trial: This trial is being conducted as part of a postgraduate medical research project. Reason for selection of topic: · Most of the research and publications have focused on its use in thoracic surgery, with a few exceptions in abdominal surgeries. In my study, I would like to focus on percutaneous nephrolithotomy surgery. · Few studies have been conducted on erector spinae plane blocks for percutaneous nephrolithotomies by using either USG-guided (or) fluoroscopy-guided erector spinae plane blocks with Inj Bupivacaine as a local anaesthetic. · I chose landmark-guided Erector spinae plane block and Inj Ropivacaine for my study. I want to compare the effectiveness of landmark-guided ESP blocks with local anaesthetic infiltration at the surgical site with Inj. Ropivacaine after PCNL surgery. |