| CTRI Number |
CTRI/2021/02/031218 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| 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
|
To study efficacy Of ultrasound guided erector spinae block for postoperative analgesia in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
To Study efficacy Of ultrasound Guided Erector Spinae Block For Postoperative Analgesia In Laproscopic Cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saroj Kumar |
| Designation |
junior resident |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
Patna
BIHAR
800014
India |
| Phone |
9470274232 |
| Fax |
|
| Email |
sarojkbng@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
associate professor |
| Affiliation |
IGIMS , Patna |
| Address |
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
Patna
BIHAR
800014
India |
| Phone |
8544413241 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
associate professor |
| Affiliation |
IGIMS , Patna |
| Address |
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
BIHAR
800014
India |
| Phone |
8544413241 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences, Patna. |
|
|
Primary Sponsor
|
| Name |
Saroj Kumar |
| Address |
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Saroj Kumar |
IGIMS, Patna |
Indira Gandhi Institute Of Medical Sciences, sheikhpura , patna
Patna
BIHAR |
9470274232
sarojkbng@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , IGIMS , Patna |
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 |
| Comparator Agent |
NSAIDS and Opioids for post operative analgesia for patients undergoing laparoscopic cholecystectomy. |
The comparative group will receive NSAIDS and Opioids for pain relief for patients undergoing laparoscopic cholecystectomy . |
| Intervention |
Ultrasound guided erector spinae block for post operative analgesia in laparoscopic cholecystectomy |
After laparoscopic cholecystectomy patients will receive 40 ml of 0.25% bupivacaine for ultrasound guided erector spinae block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA 1 and 2.
2)Consenting Patients |
|
| ExclusionCriteria |
| Details |
1)Age less than 18 and more than 65.
2)Non consenting Patients.
3)Bleeding Diathesis.
4)Pregnancy and Lactation.
5)Local skin infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| opioids consumption by patients in post operative period. |
opioids consumption by patients in post operative period for 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain score. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Erector spinae plane [ESP] block, described recently provides extensive, potent unilateral analgesia. The ESP block is performed under Ultrasonographic guidance. The aim of the study is to evaluate the efficacy of US guided ESP block for postoperative analgesia in Laproscopic Cholecystectomy. (1) Aim is to compare postoperative opioid consumption and (2) Aim is to evaluate postoperative pain score [VAS], adverse effect with opioids .
|