| CTRI Number |
CTRI/2021/07/034726 [Registered on: 09/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2021 |
| 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
|
Pain relief after laparoscopic surgeries using novel technique of instilling local anesthetic through the port sites - to study the efficacy of adding steroid to the local anesthetic |
|
Scientific Title of Study
|
Comparison of post-operative analgesia following intraperitoneal instillation of ropivacaine with and without dexamethasone in patients undergoing laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Cheran |
| Designation |
Head Of The Department, Professor |
| Affiliation |
Vinayaka Missions Medical College, Karaikal, Pondichery |
| Address |
Room No 23, Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Pondichery
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443144652 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadia Ummer |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Medical College, Karaikal, Pondichery |
| Address |
Room No 23, Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Pondichery
Karaikal
PONDICHERRY
609609
India |
| Phone |
9995771794 |
| Fax |
|
| Email |
sadiaummer91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadia Ummer |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Medical College, Karaikal, Pondichery |
| Address |
Room No 23, Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Pondichery
Karaikal
PONDICHERRY
609609
India |
| Phone |
9995771794 |
| Fax |
|
| Email |
sadiaummer91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Research Foundation, Ariyanur, Salem-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College |
| Address |
Keelakasakudimedu, Karaikal, Pondichery 609609 |
| 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 K Cheran |
Vinayaka Missions Medical College |
Room no 23, Department of Anaesthesiology, Vinayaka missions medical college, Karaikal, Pondichery
Karaikal
PONDICHERRY |
9443144652
anscheran.k73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical 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 |
Intraperitoneal instillation of Ropivacaine with dexamethasone |
Intraperitoneal instillation of Ropivacaine (0.75%) 10 ml(75 mg) with dexamethasone 16 mg (4ml) through port site in patients undergoing laparoscopic surgeries |
| Comparator Agent |
Ropivacaine with normal saline |
Intraperitoneal instillation of ropivacaine (0.75%) 10 ml(75 mg) mixed with 4 ml
normal saline through port site in patients undergoing laparoscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 Patients undergoing laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
ASA 3, 4. Patients with hypersensitivity to study drug, Patients in whom laparoscopic surgery is converted to open surgery, patients in whom abdominal drain is put, patients who are unable to express VAS score, Refusal of consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesic duration in first 24 hours, time to rescue analgesia |
Post operative analgesic duration in first 24 hours . VAS score assessed every 2 hours till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time to rescue analgesia if VAS score more than 4
Total analgesic consumption in 24 hours |
24 hours |
|
|
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)
|
20/07/2021 |
| 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="1"
Months="0"
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
|
Comparison of post operative analgesia following intraperitoneal instillation of Ropivacaine with and without dexamethasone is being studied in the context of laparoscopic surgeries. The study aims to find out the extra benefit of adding dexamethasone to the local anesthetic. Intrapereitoneal instillation through the port site does not require any extra intrvention or extra monitoring. A visual analogue scale will be used to assess the analgesic efficacy and rescue analgesia will be given if VAS score is more than 4. Patients undergoing laparoscopic surgeries will be recruited in a double bling randomised control trial. Out come parameters will be duration of analgesia, time to rescue analgesia and total analgesic requirement |