| CTRI Number |
CTRI/2020/12/030121 [Registered on: 30/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparative study of use of intraperitoneal drugs ( local anesthetics and adjuvants) for postoperative pain management after laparoscopic surgeries. |
|
Scientific Title of Study
|
comparative study of efficacy of intraperitoneal instillation of 0.2% ropivacaine with dexmedetomidine versus 0.2% ropivacaine with ketamine in laparoscopic surgeries - a randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DUDYALA DHATRI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,KALINGA INSTITUTE OF MEDICAL SCIENCES,CAMPUS 5,BHUBANESHWAR
Khordha
ORISSA
751024
India |
| Phone |
9550801246 |
| Fax |
|
| Email |
2087031@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AMRITA PANDA |
| Designation |
Associate professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology,kalinga institute of medical sciences,campus 5,patia,bhubaneshwar,khordha
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amritapanda1323@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DUDYALA DHATRI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Dept of Anesthesiology,kalinga institute of medical sciences,campus 5,patia,bhubaneshwar,khordha
Khordha
ORISSA
751024
India |
| Phone |
9550801246 |
| Fax |
|
| Email |
2087031@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
DUDYALA DHATRI |
| Address |
kims girls hostel,block b,campus 5, patia,bhuabneshwar,khordha orissa 751024 |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DUDYALA DHATRI |
kalinga institue of medical sciences |
Department of Anesthesiology
Khordha
ORISSA |
9550801246
2087031@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K811||Chronic cholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (4) ICD-10 Condition: K35||Acute appendicitis, (5) ICD-10 Condition: N832||Other and unspecified ovarian cysts, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intraperitoneal instillation in laparoscopic surgeries |
two adjuvants added to local anesthetics will be compared in terms of postoperative pain |
| Intervention |
intraperitoneal instillation of local anesthetic with adjuvant |
local anesthetic along with adjuvants will be instilled intraperitoneally in laparoscopic surgeries for postoperative pain management
Patients in Group I will receive 30ml of 0.2% Ropivacaine with dexmedetomidine 0.5μg/kg (titrated to 1ml)
Patients in Group II will receive 30ml of 0.2% Ropivacaine with ketamine 0.5mg/kg (titrated to 1ml)
Patients in Group III will receive 30ml 0.2% Ropivacaine with normal saline (1ml).
Visual analogue score will be assessed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH ASA PS I & II POSTED FOR ELECTIVE LAPAROSCOPIC SURGERIES |
|
| ExclusionCriteria |
| Details |
Patient refusal
Local anesthetic allergy / drug allergy
Pregnancy
Patients with Cardiovascular/Respiratory/ Liver/ Renal diseases
BMI ≥ 30 Kg/m2
If any other surgeries combined in the same sitting
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the total duration of analgesia and total rescue analgesic dose requirements in first 24 hours post operatively. |
for every 30 min for first two hours and then at 6 hours,12 hours and 24 hours. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
The hemodynamic parameters intraoperatively and postoperatively.
Incidence of postoperative nausea and vomiting using Likert scale.
Depth of sedation using Ramsay sedation score.
Incidence of shoulder tip pain using VAS.
|
for every 30 min for first two hours and then at 6 hours,12 hours and 24 hours. |
|
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Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2021 |
| 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="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
|
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Brief Summary
|
Postoperative pain management in laparoscopic surgeries plays a very crucial role in Enhanced Recovery After Surgery. Intraperitoneal instillation of local anesthetic will block the free nerve endings in the peritoneum and thus provide relief from visceral pain.In this study one group will receive 0.2 % Ropivacaine (30ml) with 0.5mcg/kg Dexmedetomidine (1ml) and other group will receive 0.2 % Ropivacaine (30ml) with 0.5mg/kg Ketamine (1ml). Control group will receive 0.2 % Ropivacaine (30ml) with normal saline (1ml).Three groups will be compared in terms of intensity of static and dynamic pain by VAS score for first 24 hours postoperatively. The total duration of analgesia and total analgesic dose will be compared in three groups.
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