| CTRI Number |
CTRI/2021/06/034416 [Registered on: 28/06/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| 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
|
A Study to assess the Efficacy of Erector Spinae Plane Block (ESPB) for Post operative analgesia in patients undergoing laparoscopic Cholesystectomy under General Ananesthesia |
|
Scientific Title of Study
|
A Study to assess the Efficacy of Erector Spinae Plane Block (ESPB) for Post operative analgesia in patients undergoing laparoscopic Cholesystectomy under General Ananesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepika Rajora |
| Designation |
PG Student |
| Affiliation |
Department of Anaesthesia, JLN Medical College, Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
8901445392 |
| Fax |
|
| Email |
deepikarajora44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Anaesthesia, JLN Medical College, Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Anaesthesia, JLN Medical College, Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College, Ajmer, Rajasthan
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia JLN Medical College Ajmer |
| Address |
JLN Medical College and Attached Hospitals, Ajmer, Rajasthan - 305001 |
| Type of Sponsor |
Government 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 Veena Patodi |
Department of Anaesthesia, JLN Medical College, Ajmer |
JLN Medical College and Attached Hospitals, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
9414008276
veenapatodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JLN Medical College and Attached Hospitals, Ajmer, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae Plane Block
using Normal Saline |
Erector Spinae Plane Block for poat operative analgesia using Normal Saline in patients undergoing Laproscopic Cholecystectomy under general anaesthesia. |
| Intervention |
ErectorSpinaePlaneBlock using.25% Ropivacaine |
Erector Spinae Plane Block for post operative analgesia using 0.25% ropivacaine in patients undergoing Laproscopic Cholecystectomy under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 60 years
ASA Physical Status 1 and 2
Patients with valid informed consent |
|
| ExclusionCriteria |
| Details |
BMI > 35 kg/m2
Skin infection at puncture site
Severe coagulopathy
Hypersensitivity to drugs
CVS and Respiratory diseases
Chronic Renal or liver failure
Neurological or psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative duration of analgesia |
0 to 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative intensity of pain (VAS)
Time to first rescue analgesic requirement
Total postoperative rescue analgesic consumption
Postoperative nausea and vomiting
Postoperative haemodynamic changes
Side effects or complications if any |
0 to 10 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
02/07/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
A STUDY TO ASSESS THE EFFICACY OF ERECTOR SPINAE PLANE BLOCK (ESPB) FOR POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The erector spinae block is achieved by injecting the local anasthetic solution between the erector spinae muscles (ilicostalis, longissimus, spinalis from lateral to medial) and transverse process. The local anesthetic diffuses into the paravertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of thoracic spinal nerves.6-7 In the current study, we will evaluate the efficacy of ESP block by using 0.25% ropivacaine in patients undergoing laparoscopic cholecystectomy under general anesthesia, in terms of postoperative duration of analgesia, intensity of pain, time to request for first rescue analgesic, total rescue analgesic consumption, hemodynamic changes and adverse effects/ complications. |