| CTRI Number |
CTRI/2024/05/066721 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| 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
|
Patients undergoing laparoscopic surgery for gall bladder stone or other gall bladder diseases will be divided into three groups and given ropivacaine or ropivacaine+dexmedetomidine or normal saline through nebulization in the peritoneum to compare their effect in controlling pain after surgery. |
|
Scientific Title of Study
|
Comparison of intraperitoneal nebulization of ropivacaine with ropivacaine-dexmedetomidine for pain management after laparoscopic cholecystectomy: A randomized double blind, placebo-controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karuna Mayee |
| Designation |
Junior Resident |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Rajendra Institute Of Medical Sciences
Ranchi
JHARKHAND
834009
India |
| Phone |
7050022432 |
| Fax |
|
| Email |
sameer.karuna07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shio Priye |
| Designation |
Professor |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, RIMS, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Shrivastava |
| Designation |
Assistant Professor |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, RIMS, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
9958912712 |
| Fax |
|
| Email |
shrivastava2911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India. Pin code-834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand |
| 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 Karuna Mayee |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
Department of Anesthesiology and General surgery operation theatre, RIMS, Bariatu, Ranchi, Jharkhand, India-834009
Ranchi
JHARKHAND |
7050022432
sameer.karuna07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
6ml normal saline is administered through intraperitoneal nebulization. |
6ml of normal saline is used for intraperitoneal nebulization after ports are secured for laparoscopic cholecystectomy, hemodynamic parameters are monitored till end of surgery. |
| Comparator Agent |
intraperitoneal nebulization with 0.5% ropivacaine |
4.5ml of 0.5% ropivacaine plus 1.5ml saline is used to nebulize patient intraperitoneally after ports are secured for laparoscopic cholecystectomy, hemodynamic parameters are monitored till end of surgery |
| Intervention |
Intraperitoneal nebulization with Ropivacaine-dexmedetomidine |
4.5ml of 0.5% ropivacaine plus 1mcg/kg dexmedetomidine made up to total volume of 6ml is used for intraperitoneal nebulization after the ports are secured for laparoscopic cholecystectomy then hemodynamic parameters are monitored till end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) The patient giving written and informed consent for study.
b) Patients posted for elective laparoscopic cholecystectomy.
c) Patients with ASA grade I and II.
d) Male and female patients aged between 18-70 years.
|
|
| ExclusionCriteria |
| Details |
a. Patients having a clinical diagnosis of acute pancreatitis.
b. Patients having acute preoperative pain other than biliary colic.
c. Patients undergoing chronic pain treatment or on anti-epileptic.
therapy.
d. Patients with severe renal or hepatic impairment.
e. Patients with history of alcohol or drug addiction.
f. Patients having allergy to the study drugs.
g. Patients with cognitive impairment or communication problems.
h. Pregnant or lactating patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To record the time of requirement of first rescue analgesic. |
Visual Analogue Scale Score
3hours post-surgery
6hours post-surgery
12hours post-surgery
24hours post-surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To record the hemodynamic parameters- systolic blood pressure, diastolic blood pressure, heart rate and MAP every after intraperitoneal nebulization till the end of surgery.
b) To record incidence of nausea and vomiting after the operative procedure to the requirement of first rescue analgesic. |
Baseline
5minutes after nebulization
10minutes after nebulization
15minutes after nebulization
30minutes after nebulization
45minutes after nebulization
60minutes after nebulization
75minutes after nebulization
90minutes after nebulization
105minutes after nebulization |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 4 |
|
Date of First Enrollment (India)
|
13/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy is the treatment of choice in case of cholelithiasis. Intraperitoneal nebulization with ropivacaine with dexmedetomidine intends to provide better control of pain post surgery. |