CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/09/094011 [Registered on: 01/09/2025] Trial Registered Prospectively

Last Modified On:

29/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

EFFICACY OF INTRAPERITONEAL INSTILLATION OF ROPIVACAINE WITH DEXMEDETOMIDINE VERSUS BUPIVACAINE WITH DEXMEDETOMIDINE FOR POST OPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY; RANDOMISED CONTROLLED TRIAL

Scientific Title of Study

A Randomized Controlled Trial to Evaluate the Efficacy of Intraperitoneal Instillation of Ropivacaine with Dexmedetomidine versus Bupivacaine with Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy"

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 Prakriti Choudhury
Designation	Post Graduate Trainee
Affiliation	Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences
Address	Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar; Khordha; Orissa; 751024; India Khordha ORISSA 751024 India
Phone	9706126777
Fax
Email	2487018@kims.ac.in

Details of Contact Person
Scientific Query

Name	Prof. Dr. Mousumi Das
Designation	Professor
Affiliation	Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences
Address	Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar; Khordha; Orissa; 751024; India Khordha ORISSA 751024 India
Phone	9937928790
Fax
Email	mousumi.das1503@gmail.com

Details of Contact Person
Public Query

Name	Dr Prakriti Choudhury
Designation	Post Graduate Trainee
Affiliation	Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences
Address	Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar; Khordha; Orissa; 751024; India Khordha ORISSA 751024 India
Phone	9706126777
Fax
Email	2487018@kims.ac.in

Source of Monetary or Material Support

KALINGA INSTITUTE OF MEDICAL SCIENCES

Primary Sponsor

Name	Dr Prakriti Choudhury
Address	Department of Anaesthesiologist, KIIT Deemed to be university, Bhubaneswar, PIN 751024 university,Bhubaneswar,PIN:751024
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Prakriti Choudhury	Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences	Department of Anaesthesia Kalinga Institute of Medical Sciences,Bhubaneswar,751024 Khordha ORISSA Khordha ORISSA	9706126777 2487018@kims.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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 Bupivacaine 0.25% (35 mL) with Dexmedetomidine 0.5 mcg/kg	Route: Intraperitoneal Timing: At the end of surgery, before trocar removal Frequency: Single administration Duration: One-time administration during surgery Group: Intervention Group (Group 1) Administered by: Surgeon Blinding: Patient and primary investigator are blinded Group 2: Will receive intraperitoneal 35 mL of 0.25% Bupivacaine with 0.5mcg/kg dexmedetomidine
Comparator Agent	Intraperitoneal instillation of Bupivacaine 0.25% (35 mL) with Dexmedetomidine 0.5mcg/kg	Route: Intraperitoneal Timing: At the end of surgery, before trocar removal Frequency: Single administration Duration: One-time administration during surgery Group: Comparator Group (Group 2) Administered by: Surgeon Blinding: Patient and primary investigator are blinded

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	ASA grade I or II Age between 18 and 65 years Hemodynamically stable Undergoing elective laparoscopic cholecystectomy Provided written informed consent

ExclusionCriteria

Details

Emergency procedures

Significant comorbidities
(neurological, cardiac,
respiratory, metabolic,
hepatic, renal)

Coagulation disorders

Known allergy to study
drugs

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome

Outcome	TimePoints
The time duration (in hours) from the completion of surgery to the time patient requested for first rescue analgesic medication.	From the end of surgery (trocar removal) until the first patient request for rescue analgesia, within the first 24 hours postoperatively.

Secondary Outcome

Outcome	TimePoints
1 .The total rescue analgesic dose requirements in first 24 hours post operatively. 2. The intensity of pain using Visual Analog Scale (VAS) score Immediately postoperatively Hourly up to first 4 hours(1,2,3,4 hrs) Every 4 hours upto 12 hours(8,12 hrs) At 24 hours 3.Heart Rate(bpm) & MAP(mmHg) (Observation time same as vas)	Immediately postoperatively Hourly up to first 4 hours(1,2,3,4 hrs) Every 4 hours upto 12 hours(8,12 hrs) At 24 hours

Target Sample Size

Total Sample Size="92"
Sample Size from India="92"
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)

30/09/2025

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="2"
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

This randomized, double-blind clinical trial aims to compare the analgesic efficacy of intraperitoneal instillation of 0.25% bupivacaine versus 0.25% ropivacaine, both combined with dexmedetomidine (0.5 mcg/kg), in patients undergoing elective laparoscopic cholecystectomy. Conducted at KIMS, Bhubaneswar from August 2025 to July 2027, the study includes 92 ASA I/II patients aged 18–65 years. The primary outcome is the time to first rescue analgesia; secondary outcomes include total analgesic requirement, VAS pain scores, heart rate, and MAP over 24 hours. The study follows standardized anesthesia protocols and pain assessments.