| CTRI Number |
CTRI/2020/09/028020 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
23/09/2020 |
| 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
|
To study the effectiveness of two different types of local anaesthetic drugs for pain relief after surgery, instilled around the gall bladder in laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
A comparative study of intraperitoneal instillation of Bupivacaine(0.5%) and Ropivacaine (0.5%) 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 Sachin M |
| Designation |
Post graduate student |
| Affiliation |
KIMS, Bengaluru |
| Address |
Room no 215,
KIMS Residential Quarters,
KIMS, Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9972788051 |
| Fax |
|
| Email |
sachin.mahadev18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini A |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bengaluru |
| Address |
Department of Anaesthesia,
KIMS, Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9341231411 |
| Fax |
|
| Email |
dr.ashwinivijay.a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini A |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bengaluru |
| Address |
Department of Anaesthesia,
KIMS, Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9341231411 |
| Fax |
|
| Email |
dr.ashwinivijay.a@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda Institute of Medical Science |
|
|
Primary Sponsor
|
| Name |
Dr Sachin M |
| Address |
Room No 215,
KIMS Residential Quarters,
KIMS, Bengaluru |
| 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 |
| Dr Sachin M |
Kempegowda Institute of Medical Sciences |
Department of Anaesthesia, Kempegowda Institute of Medical Sciences,
V V Puram,
Bengaluru
Bangalore
KARNATAKA |
9972788051
sachin.mahadev18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine 0.5% Vs Ropivacaine 0.5% |
To evaluate the duration of post operative analgesia of 0.5% Bupivacaine and 0.5% Ropivacaine following postoperative intraperitoneal instillation of 0.5% Bupivacaine (15ml) and 0.5% Ropivacaine (15ml) instilled intraperitoneally
Hemodynamic changes following intraperitoneal instillation of 0.5% Bupivacaine (15ml) and 0.5% Ropivacaine (15ml)
To assess the need of rescue analgesia in post operative period in both the groups. |
| Comparator Agent |
Bupivacaine 0.5% Vs Ropivacaine 0.5% |
To evaluate the duration of post operative analgesia of 0.5% Bupivacaine and 0.5% Ropivacaine following postoperative intraperitoneal instillation.
Hemodynamic changes following intraperitoneal instillation of Bupivacaine and Ropivacaine.
To assess the need of rescue analgesia in post operative period in both the groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Weighing between 50-70kg.
ASA 1 and 2 physical status.
|
|
| ExclusionCriteria |
| Details |
Local anaesthetic hypersensitivity.
Allergy to drugs used.
Emergency laparoscopies.
Regular use of NSAIDs and analgesics.
Uncontrolled systemic disorders.
Acute cholecystitis patients.
Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analog scale for pain.
Hemodynamic changes.
Total analgesic requirement in the first 24hours. |
Visual analog scale for pain.
Hemodynamic changes.
Total analgesic requirement in the first 24hours. 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/09/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the effectiveness of bupivacaine and ropivacaine instilled intraperitoneally in laparoscopic cholecystectomy cases, and to assess the need of rescue analgesia post operatively in both the groups. |