| CTRI Number |
CTRI/2024/04/065654 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to know the usefulness of Nerve block for pain management post surgery under help of ultrasound machine in patient undergoing PCNL Surgery |
|
Scientific Title of Study
|
A Prospective randomized double blinded controlled study based on usefulness of Erector spinae block under ultrasound guidance versus control in patient undergoing PCNL Surgery. |
| 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 Anagha Vinod |
| Designation |
First year DNB Anesthesia Candidate |
| Affiliation |
Sri Narayani Hospital and Research Centrere |
| Address |
Sri Narayani Hospital and Research Centre
Sripuram
Vellore
Vellore
TAMIL NADU
632055
India |
| Phone |
9074205519 |
| Fax |
|
| Email |
anagha9656909712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. SIDDARTHA. S |
| Designation |
CONSULTANT ANAESTHESIA |
| Affiliation |
Sri Narayani Hospital and Research Centrere |
| Address |
Department of Anesthesia, C block, Room no 401,
Sri Narayani Hospital and Research Centre
Sripuram
Vellore
Vellore
TAMIL NADU
632055
India |
| Phone |
9626888412 |
| Fax |
|
| Email |
seekala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anagha Vinod |
| Designation |
First year DNB Anesthesia Candidate |
| Affiliation |
Sri Narayani Hospital and Research Centre |
| Address |
Sri Narayani Hospital and Research Centre
Sripuram
Vellore
Vellore
TAMIL NADU
632055
India |
| Phone |
9074205519 |
| Fax |
|
| Email |
anagha9656909712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Narayani Hospital and Research Centre.
Sripuram, Vellore.
Tamil nadu.
India.
Pin code - 632055 |
|
|
Primary Sponsor
|
| Name |
Sri narayani hospital and research centre |
| Address |
Thirumalaikodi
Vellore
Tamil nadu
Pin code-632055 |
| 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 Anagha Vinod |
Sri Narayani Hospital and Research Centre |
Department of Anesthesia.
C block, Room no 401,
Vellore,
Tamil nadu,
India.
Pin code - 632055
Vellore
TAMIL NADU |
9074205519
anagha9656909712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Narayani Hospital and Research Centre Institutional Ethic committee |
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 Block |
Erector Spinae Block using 110 mm sonotap needle. 20 ml of 0.25 percent of Bupivacaine at T 12 and T 10 level, 10 ml at each level, post operative before extubation. VAS Score for pain will be assessed at 0 hour (patient is awake and able to assess pain on VAS Score properly) 1,2,3,4,5,6,10,14,18,24 Postoperative hours. |
| Comparator Agent |
Normal saline |
Ultrasound guided ESP Block using 110 mm sonotap needle, 20ml of Normal saline (each 10 ml) at T 10 and T 12 level,post operative before extubation. VAS Score for pain will be assessed at 0 hour (patient is awake and able to assess pain on VAS Score properly) 1,2,3,4,5,6,10,14,18,24 Postoperative hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of Anesthesiologist I and II
2.Patient with BMI more than 35 |
|
| ExclusionCriteria |
| Details |
1.patient with excessive bleeding
2.patients having supracostal puncture.
3.significant residual stone more than 1 cm and need for second look.
4.solitary kidney
5.dermal infection in the injection site
6.contrast and drug allery
7.Body mass index more than 35
7.Surgery lasting more than 180 minutes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Favourable outcome is expected for ultrasound guided ESP Block in comparison to control group. |
1 hour, 2 hour, 3 hour, 4 hour,5 hour, 6 hour, 10 hour, 14 hour, 18 hour, 24 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesic requirement in 24 hour and Postoperative opioid consumption. |
1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 10 hour, 14 hour, 18 hour, 24 hour. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A Prospective randomized double blinded controlled study based on usefulness of Erector spinae block under ultrasound guidance versus control in patient undergoing PCNL Surgery for the duration of 1 year in which favourable outcome for ultrasound guided ESP Block in comparison to control group. PCNL is one most popular surgical procedure to remove renal stones through small puncture through the skin. PCNL has evolved remarkably since the eighties when it was first described. The cause of the Postoperative pain in this surgery is due to distention of renal capsule, pelvicalyceal system and nephrostomy tube placed after surgery. Pain due to surgery is both visceral (from kidney and ureter - (T10 to T12)) and somatic pain (T 8 - T 12). Various option such as use of opioids, NSAID and other pain medications are used to decrease the pain but have side effects such as nausea, vomiting, constipation tolerance etc. For this study, there will be two groups to evaluate the efficacy of Erector spinae block with. 25 percent of Bupivacaine (20 ml) 50 mg versus control group Normal saline (20ml) for Postoperative duration of pain, Postoperative analgesic consumption and assess effects on pain score. Aim of the study is to do a comparative study of Postoperative analgesia between ultrasound guided ESP Block and versus control group in PCNL Surgery. The primary objective is assessment of duration of Postoperative analgesia and secondary objective is Total analgesic requirement in 24 hour and Postoperative opioid consumption. |