| CTRI Number |
CTRI/2023/05/052379 [Registered on: 08/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the efficacy of Ropivacaine alone vs ropivacaine with dexmedetomidine for post operative analgesia in laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
COMPARISON OF INTRAPERITONEAL INSTILLATION WITH ROPIVACAINE ALONE AND ROPIVACAINE PLUS DEXMEDETOMIDINE FOR POST OPERATIVE ANALGESIA IN 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 |
Dr Puneet Bhardwaj |
| Designation |
Secondary DNB Anaesthesia |
| Affiliation |
Hindu Rao Hospital AND NDMC Medical College |
| Address |
Department of Anaesthesia,
Hindu Rao Hospital and North DMC medical College, Malkaganj, Delhi-110007
North
DELHI
110007
India |
| Phone |
|
| Fax |
|
| Email |
puneetbhardwaj@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka Chandra |
| Designation |
SPECIALIST AND HEAD OF DEPARTMENT DEPARTMENT OF ANAESTHESIOLOGY CRITICAL CARE AND PAIN MEDICINE |
| Affiliation |
HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE |
| Address |
Department of Anaesthesia,
Hindu Rao Hospital and North DMC medical College, Malkaganj,Delhi-110007
North
DELHI
110007
India |
| Phone |
|
| Fax |
|
| Email |
dralkadelhi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Chandra |
| Designation |
SPECIALIST AND HEAD OF DEPARTMENT DEPARTMENT OF ANAESTHESIOLOGY CRITICAL CARE AND PAIN MEDICINE |
| Affiliation |
HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE |
| Address |
Department of Anaesthesia,
Hindu Rao Hospital and North DMC medical College, Malkaganj,Delhi-110007
North
DELHI
110007
India |
| Phone |
|
| Fax |
|
| Email |
dralkadelhi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| HINDU RAO HOSPITAL AND NORTH DMC MEDICAL COLLEGE, MALKAGANJ, DELHI-110007 |
|
|
Primary Sponsor
|
| Name |
HINDU RAO HOSPITAL AND NORTH DMC MEDICAL COLLEGE |
| Address |
HINDU RAO HOSPITAL AND NORTH DMC MEDICAL COLLEGE,
MALKAGANJ,
DELHI-110007 |
| 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 ALKA CHANDRA |
HINDU RAO HOSPITAL |
DEPARTMENT OF ANAESTHESIA, HINDU RAO HOSPITAL AND NORTH DMC MEDICAL COLLEGE,
MALKAGANJ,
DELHI-110007
North
DELHI |
9560044454
dralkadelhi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraperitoneal Instillation of Ropivacaine in laparoscopic cholecystectomy |
Intraperitoneal Instillation of 18 ml of 0.5% ropivacaine with 2 ml of 0.9% NaCl to make total volume of 20ml will be done at gall Bladder bed at the end of surgical procedure. |
| Intervention |
Intraperitoneal instillation of ropivacaine with dexmedetomidine in laparoscopic cholecystectomy |
Intraperitoneal instillation 18 ml of 0.5% ropivacaine with 1mcg/kg dexmedetomidine with 0.9% NaCl to make total volume of 20ml will be done at gall Bladder bed at the end of surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing elective laparoscopic cholecystectomy
2. Patient belonging to ASA physical status grade 1 and grade 2 |
|
| ExclusionCriteria |
| Details |
1. Patients refusing to participate in the study.
2. Patients with known allergy to drugs used in the study.
3. Patient with basal heart rate <60 beats per minute.
4. Patient with suspected malignancy
5. Patient having abdominal drain at the end of surgery.
6. Laparoscopic surgery converted to open cholecystectomy.
7. Patient undergoing CBD Exploration during surgery.
8. patient with history of cardiac , respiratory, renal or hepatic disease.
9. Pregnant Females |
|
|
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 measure VAS score for post operative pain |
1)T0- Time at arrival of patient in PACU
2)T1- 30 minutes after arrival in PACU
3)T2- 60 minutes after arrival in PACU
4)T3- 120 minutes after arrival in PACU
5)T4- 240 minutes after arrival in PACU
6)T5- 360minutes after arrival in PACU
7)T6- 720 minutes after arrival in PACU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) to measure time interval to first dose of rescue analgesia and total dose of rescue analgesia
2) to measure hemodynamic parameters in both groups
3)to measure the level of sedation in both groups
4) any incidence of adverse effects |
1)T0- Time at arrival of patient in PACU
2)T1- 30 minutes after arrival in PACU
3)T2- 60 minutes after arrival in PACU
4)T3- 120 minutes after arrival in PACU
5)T4- 240 minutes after arrival in PACU
6)T5- 360minutes after arrival in PACU
7)T6- 720 minutes after arrival in PACU |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
08/05/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to improve post operative analgesia for laparoscopic cholecystectomy. Intraperitoneal instillation of local anesthetic agents provide post operative analgesia in laparoscopic cholecystectomy. The study will compare intraperitoneal instillation of ropivacaine to dexmedetomidine plus ropivacaine for post operative analgesia in laparoscopic cholecystectomy. |