CTRI

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CTRI Number

CTRI/2024/04/065789 [Registered on: 16/04/2024] Trial Registered Prospectively

Last Modified On:

06/12/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison of usual analgesics with opioids in short lower abdominal gynaecological procedure for pain relief

Scientific Title of Study

COMPARISON OF OPIOID FREE WITH OPIOID BASED ANAESTHESIA IN ELECTIVE DILATATION AND CURETTAGE: A RANDOMISED TRIAL

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 SWETA PANNA MISHRA
Designation	PRIMARY DNB RESIDENT
Affiliation	BOKARO GENERAL HOSPITAL
Address	ROOM NO 07 AYUSHMAN WARD BOKARO GENERAL HOSPITAL SECTOR 04 BOKARO JHARKHAND Bokaro JHARKHAND 827004 India
Phone	9740819931
Fax
Email	punpunmishra14@gmail.com

Details of Contact Person
Scientific Query

Name	Dr A K DAM
Designation	Additional CMO and Head of Department of Anaesthesiology
Affiliation	Bokaro general hospital
Address	Bokaro general hospital Sec 4 Bokaro steel city bokaro Bokaro JHARKHAND 827004 India
Phone	8789976351
Fax
Email	RATULDAM@yahoo.com

Details of Contact Person
Public Query

Name	DR P K DWIVEDI
Designation	Chief Consultant
Affiliation	Bokaro general hospital
Address	Bokaro general hospital Sec 4 Bokaro steel city bokaro Bokaro JHARKHAND 827004 India
Phone	8986873083
Fax
Email	drprabhatkumardwivedi@gmail.com

Source of Monetary or Material Support

Department of Anaesthesiology, Bokaro General Hospital, Bokaro, Jharkhand, India Pin code 827004

Primary Sponsor

Name	BOKARO GENERAL HOSPITAL
Address	Bokaro General Hospital, Bokaro Steel city BOKARO JHARKHAND 827004
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 SWETA PANNA MISHRA	BOKARO GENERAL HOSPITAL	Bokaro General Hospital sec 4 Bokaro steel city Jharkhand 827004 Bokaro JHARKHAND	9740819931 punpunmishra14@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTINAL ETHICAL COMMITTEE Bokaro General Hospital	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, (2) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Opioid based anaesthesia	Intravenous Fentanyl (0.75mcg/kg) and intravenous Diclofenac 75 mg slowly via intravenous route over 2 minutes, 5 minutes prior to surgery. Sleep dose of propofol is given after positioning of patient. nitrous oxide and oxygen is given in ratio of 1:1 via standard face mask.
Intervention	Opioid free anaesthesia	Intravenous 2% Lidocaine (1.5mg/kg) and intravenous Diclofenac 75 mg slowly via intravenous route over 2 minutes, 5 minutes prior to surgery. Sleep dose of propofol is given after positioning of patient. nitrous oxide and oxygen is given in ratio of 1:1 via standard face mask.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	1. ASA I 2. ASA II 3. Patient willing to give written informed consent to be a part of the study.

ExclusionCriteria

Details

1. Patient refusal to provide consent.
2. Patient with history of drug abuse.
3. Patient with history of psychotropic medications or psychological disorders.
4. Patient with morbid obesity.
5. Patient allergic to any of the study drugs, use of medications or nutraceuticals that affects blood pressure or heart rate.
6. Surgical procedure exceeding 1 hour duration.
7. Patient with unexpected bleeding complications.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
To determine if opioid free anaesthesia is effective	Pain score based on visual analogue scale 5mins 15mins 30mins

Secondary Outcome

Outcome	TimePoints
To determine the efficacy of opioid free anaesthesia when compared to opioid based anaesthesia in tackling perioperative pain	Pain score based on comparative visual analogue scale 5mins 15mins 30mins

Target Sample Size

Total Sample Size="180"
Sample Size from India="180"
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)

25/04/2024

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="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

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
Modification(s)

Acute post operative pain is a concern.Inadequate pain control can result in the patient dissatisfaction,prolonged hospital stays and increased morbidity.Opioid free anaesthesia refers to the perioperative utilisation of opioid sparing technique for intraoperative hemostasis leading to complete avoidance of intraoperative opioids without causing any patient discomfort .Dilatation and curettage is one of the most common gynaecological procedure.Opioid free anaesthesia using iv lidocaine is not much in practise .In order to see the efficacy of opioid free anaesthesia using iv lidocaine this study has been proposed .

Group A (n=90) will be receiving iv lidocaine (1.5mg/kg) slow iv push over a period of 2 minutes at least 5 minutes prior to onset of surgery.

Group B(n=90) will be receiving iv fentanyl (0.75mcg/kg) slow iv push over a period of 2 minutes at least 5 minutes prior to onset of surgery.

Both the groups will be receiving iv diclofenac sodium (75mg) given by slow iv 5 minutes prior to onset of surgery .Following which patient will be positioned for dilatation and curettage. After positioning a sleep dose of propofol will be given . Nitrous oxide and oxygen will be given in ratio of 1:1 via standard face mask of appropriate size. Before injection of drugs vitals will be taken . Intraoperative blood pressure,heart rate ,respiratory rate will be monitored and total cumulative dosage of propofol will be calculated .The patient wil be monitored for post operative pain by VAS scoring at 5mins15mins and 30mins .Patient will be observed for any rescue analgesia ( iv fentanyl 25mcg ) required .