CTRI

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CTRI Number

CTRI/2022/05/042384 [Registered on: 05/05/2022] Trial Registered Prospectively

Last Modified On:

30/04/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Other

Public Title of Study

Comparison of effects of wound infiltration with Dexamethasone versus Dexmedetomidine with Ropivacaine on post operative pain in Laparoscopic Cholecystectomy

Scientific Title of Study

Comparison of effects of port site infiltration with Dexamethasone versus Dexmedetomidine as adjuvant to Ropivacaine on post operative analgesia in Laparoscopic Cholecystectomy

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Nupur Aggarwal
Designation	Pg 2nd year Anaesthesia
Affiliation	school of medical sciences and research
Address	Department of Anaesthesiology, school of medical sciences and research, plot no 32, 34, knowledge park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	09654145106
Fax
Email	NUPUR.AGGARWAL@SHARDA.AC.IN

Details of Contact Person
Scientific Query

Name	Dr Mahendra Kumar
Designation	Professor
Affiliation	school of medical sciences and research
Address	Department of Anaesthesiology, school of medical sciences and research, plot no 32, 34, knowledge park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	8287188449
Fax
Email	mahendra.kumar@sharda.ac.in

Details of Contact Person
Public Query

Name	Dr Nupur Aggarwal
Designation	Pg 2nd year anaesthesia
Affiliation	school of medical sciences and research
Address	Department of Anaesthesiology, school of medical sciences and research, plot no 32, 34, knowledge park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9654145106
Fax
Email	nupur.aggarwal@sharda.ac.in

Source of Monetary or Material Support

sharda hospital

Primary Sponsor

Name	sharda hospital
Address	plot no 32, 34, knowledge park 3, greater noida
Type of Sponsor	Private medical college

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 Nupur Aggarwal	sharda hospital, school of medical sciences and research	Department of Anaesthesiology, 2nd floor, b block Gautam Buddha Nagar UTTAR PRADESH	9654145106 nupur.aggarwal@sharda.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	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	Dexamethasone	Before closure of surgical wound, all 4 port sites will be infiltrated with Ropivacaine (0.5%) 20mL plus dexamethasone 8mg diluted in NS to make 4mL (total volume-24mL)
Intervention	Dexmedetomidine	Before closure of surgical wound, all 4 port sites will be infiltrated with Ropivacaine (0.5%) 20mL plus dexmedetomidine 50mcg diluted in NS to make 4mL (total volume-24mL)
Comparator Agent	Ropivacaine	Before closure of surgical wound, all 4 port sites will be infiltrated with Ropivacaine (0.5%) 20mL plus 4mL 0.9% Normal saline (NS) (total volume-24mL)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patients scheduled for elective laparoscopic cholecystectomy through four ports under general anaesthesia. 2. ASA class I and II 3. Age 18-60 years 4. Both genders

ExclusionCriteria

Details

1. Patients receiving steroids, analgesics, antiemetic and sedatives.
2. Patients with past history of chronic pain.
3. Patients having history of endocrine, cardiovascular, renal or CNS disease.
4. Patients allergic to study drugs.
5. BMI > 30 kg m-2

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 compare the post operative pain score following port site infiltration with dexamethasone versus dexmedetomidine as adjuvant to ropivacaine (0.5%) in the patients of laparoscopic cholecystectomy.	upto 24 hours

Secondary Outcome

Outcome	TimePoints
1.To compare the duration of post operative analgesia in three groups 2. To compare the hemodynamic parameters (HR, SBP, DBP, MAP) post operatively 3. To compare the incidence of PONV in three groups 4. To compare the sedation score in three groups	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)

09/05/2022

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="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

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 mainstay treatment of gall bladder diseases due to its advantages such as less postoperative pain, short hospital stay, better cosmetic results, and less cost over open cholecystectomy.

40% of the patients manifest pain of moderate to severe intensity in the first 24 hours after laparoscopic cholecystectomy, with a predominance of incisional pain in incidence and intensity, compared with visceral pain and referred pain to the shoulder.

Postoperative pain management not only minimizes patient suffering but also can reduce cardio-respiratory morbidity and facilitate rapid recovery. Multimodal analgesia is one of the techniques used to treat postoperative pain which, when combining medications with additive or synergistic effects and different mechanisms of action, not only improves the efficiency of individual drug but also reduces their secondary effects.

Although regional anaesthetic techniques, such as epidural analgesia or perineural catheters, have proven to provide excellent analgesia, many of these analgesic modalities are time consuming, expensive, and has side effects such as dislocation of catheters or catheter infection.

As a significant proportion of surgical pain originates from the surgical wound, incisional infiltration with local anaesthetics would seem logical to manage perioperative pain. Local wound infiltration is an efficacious strategy with minimal side effects.

Nowadays, there is a trend toward preferring ropivacaine over other local anaesthetic agents due to longer duration of action and better safety profile.

Local anaesthetic infiltration, however, has a limitation in pain relief as it is effective till the effects of local anaesthetic action lasts, which can further extended by using adjuvants to local anaesthetic agents like dexamethasone, dexmedetomidine etc. Glucocorticoids are indicated for the relief of incisional pain in several surgical procedures as the inflammation caused by tissue injury plays an important role in pain.

Dexamethasone can be used alone or as an adjuvant treatment. However, the usual route of administration to increase the duration of the analgesia and to reduce the intensity of the pain is intravenous. Other routes of use such as local infiltration provides maximum concentration of drug at the wound site and with lower systemic toxicity.

Recently Dexmedetomidine, a highly selective alpha 2-adrenergic receptor agonist has been used by various routes including local infiltration as adjuvant to local anaesthestic agents for postoperative analgesia. It has the broad spectrum properties (sedative, analgesic and anaesthetic sparing), making it a useful and safe adjunct in many clinical applications.

Both drugs Dexamethasone and Dexmedetomidine have been used as adjuvants to local anaesthetics in wound infiltration for post operative pain relief.

Extensive search of literature did not reveal any study to compare the effects of these two drugs as adjuvant to Ropivacaine in port site infiltration in the patients of laparoscopic cholecystectomy. So, in the present study, both drugs will be used as adjuvant to ropivacaine to compare their effect on post operative pain following their infiltration at the port sites in laparoscopic cholecystectomy.