| CTRI Number |
CTRI/2025/01/079253 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Analgesic efficacy of intraperitoneal instillation of dexamethasone and bupivacaine versus bupivacaine in patient undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Analgesic efficacy of intraperitoneal instillation of dexamethasone and bupivacaine versus bupivacaine in patient undergoing laparoscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Kamble |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9594095760 |
| Fax |
|
| Email |
kambleprachi022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Chaudhary Verma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788378382 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeta Chaudhary Verma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788378382 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, 442001
|
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India 442001 |
| 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 Prachi Kamble |
Jawaharlal Nehru Medical College |
Department of
Anaesthesiology,
Jawaharlal Nehru
Medical College,
Sawangi Meghe,
Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9594095760
kambleprachi022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bupivacaine |
Bupivacaine is the potent local anaesthetic drug. which is commonly used in giving blocks and in regional anaesthesia.inj bupivacaine will be given 0.25% 40ml alone without other adjuvant drug. |
| Intervention |
DEXAMETHASONE AND BUPIVACAINE |
Dexamethsone is the corticosteroids. it is commonly used in inflammatory conditions.Bupivacaine is a potent local anethesia drug. Hence in the study bupivacaine 0.25% 40 ml with 12mg dexamethsone will be used intraoperatively and will be given intraperitoneally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study
ASA grade one to two.
Patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients of age group less than eighteen years and above sixty years.
ASA grade three to four.
Patients with history of Diabetes mellitus.
Patient allergic to the study drug.
Pregnant females.
Patients with history of previous abdominal surgeries.
laparoscopic cholecystectomy got converted to open
cholecystectomy.
Patients on steroids. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient receiving dexamethasone 12mg along with bupivacaine 0.25% 4o ml had a significantly longer duration of analgesia |
Pre operatively and post operatively - baseline, 1 hourly, 2 hourly, 4 hourly, 8 hourly, 12 hourly, 16 hourly, 24 hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time of the first rescue.
To compare the time to total rescue analgesic done.
To study the post operative nausea,vomiting, hypergycemia and any adverse effect among the group. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 2 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
After selecting patients on the basis of the inclusion and exclusion criteria posted electively for laparoscopic cholecystectomy will be given Intraperitoneal instillation of injection Dexamethsone 12mg with 0.25% injection Bupivacaine 40ml is expected to significantly reduces post operative pain and requirment of rescue analgesic compared to 0.25% injection Bupivacaine 40ml alone. |