| CTRI Number |
CTRI/2022/06/043492 [Registered on: 24/06/2022] Trial Registered Prospectively |
| Last Modified On: |
16/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ESP block & gall bladder bed and port site infiltration in laparoscopic cholecystectomy patients |
|
Scientific Title of Study
|
“Comparative study between USG guided bilateral erector spinae block and conventional gall bladder bed instillation with port site infiltration with local anesthetics in laparoscopic cholecystectomy for postoperative pain relief†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALAJANGI PRASEEDA |
| Designation |
post graduate student |
| Affiliation |
Institute of Medical Sciences and SUM hospital |
| Address |
Dept. Of Anaesthesiology, 1st floor,IMS & SUM Hospital,SECTOR 8,kalinga nagar, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
8885002288 |
| Fax |
|
| Email |
praseedakalyani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF SWASTIKA SWARO |
| Designation |
Professor and Guide |
| Affiliation |
Institute of Medical Sciences and SUM hospital |
| Address |
Dept. Of Anaesthesiology,1ST floor,IMS & SUM hospital,Sector 8, kalinga nagar , Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9861628628 |
| Fax |
|
| Email |
drswastika81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ALAJANGI PRASEEDA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Institute of Medical Sciences and SUM hospital |
| Address |
Dept. Of Anaesthesiology,1ST FLOOR,IMS & SUM hospital,Sector 8, kalinga nagar,Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
8885002288 |
| Fax |
|
| Email |
praseedakalyani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Medical Sciences And SUM Hospital Dept. Of Anaesthesiology,Pain,Palliative And Critical Care K-8 , kalinga nagar Bhubaneswar, Odisha
|
|
|
Primary Sponsor
|
| Name |
Dr Alajangi Praseeda |
| Address |
Institute Of Medical Sciences And SUM Hospital Dept. Of Anaesthesiology,Pain,Palliative And Critical Care K-8 , kalinga nagar Bhubaneswar, Odisha
|
| 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 |
| DrAlajangi Praseeda |
Institute Of Medical Sciences and SUM Hospital |
Modular OT complex,1st floor,Dept. Of Anaesthesiology,Pain,Palliative And Critical Care K-8 , kalinga nagar Bhubaneswar, Odisha
Khordha
ORISSA |
8885002288
praseedakalyani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
Bilateral erector spinae block |
DRUG:0.25% bupivacaine
DOSAGE:40ml
23G spinal needle for block
frequency: 0,2,4,6,12,24 hrs
duration: 24hrs postoperatively
|
| Comparator Agent |
Gall bladder bed instillation with port site infiltration |
DRUG: 0.25% bupivacaine
DOSAGE:30ml at gall bladder bed
10ml at port site
infiltration
frequency: 0,2,4,6,12,24 hrs
duration: 24hrs postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2 |
|
| ExclusionCriteria |
| Details |
Refusal by patient
Allergy to study drug
Contraindication to regional anesthesia
ASA 3,4
Neurological diseases
Conversion from laparoscopic to open surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and measure the duration of postoperative analgesia and
First need of rescue analgesia |
24hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vitals monitoring
visual analog scale
patient satisfaction score
Incidence of side effects |
upto 24hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2022 |
| 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="0"
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
|
This study is a Randomized, double blinded ,parallel group trail comparing the efficacy of post operative pain relief between ultrasound guided bilateral erector spinae plane block and conventional gall bladder bed instillation & port site infiltration of local anesthetics in patients undergoing laparoscopic cholecystectomy. This trial will be conducted in 60 patients with ASA grades 1 & 2 in India. The primary outcome is to measure and compare the duration of postoperative analgesia and first need of rescue analgesia. Secondarily, to compare quality of pain relief, monitoring vitals & side effects. |