CTRI

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CTRI Number

CTRI/2017/07/009102 [Registered on: 24/07/2017] Trial Registered Retrospectively

Last Modified On:

21/07/2017

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

To study the effectiveness of addition of the drug clonidine to the local anesthetic drug ropivacaine for use in ultrasound guided transversus abdominis plane block in adult patients undergoing kidney transplantation surgery

Scientific Title of Study

To study the efficacy of clonidine as an adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block in adult renal transplant recipients- a double blinded randomised controlled trial.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Sayan Nath
Designation	Junior resident
Affiliation	All India Institute of Medical Sciences, New delhi
Address	Department of Anaesthesiology, Pain medicine and Critical care, Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi Ansari Nagar, New Delhi South DELHI 110029 India
Phone
Fax
Email	sayannathcmc2@yahoo.com

Details of Contact Person
Scientific Query

Name	Mahesh Kumar Arora
Designation	Professor and Head
Affiliation	All India Institute of Medical Sciences, New delhi
Address	Department of Anaesthesiology, Pain medicine and Critical care, Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi Ansari Nagar, New Delhi South DELHI 110029 India
Phone
Fax
Email	mkarora442@gmail.com

Details of Contact Person
Public Query

Name	Mahesh Kumar Arora
Designation	Professor and Head
Affiliation	All India Institute of Medical Sciences, New delhi
Address	Department of Anaesthesiology, Pain medicine and Critical care, Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi Ansari Nagar, New Delhi DELHI 110029 India
Phone
Fax
Email	mkarora442@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences, Ansari Nagar East, New Delhi-110029

Primary Sponsor

Name	All India Institute of Medical Sciences
Address	Ansari Nagar East, New Delhi: 110029
Type of Sponsor	Research institution and hospital

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 Sayan Nath	All India Institute of Medical Sciences	Department of Anesthesiology, Pain Medicine and Critical Care, Room number;5011,5th floor, Teaching block South DELHI	9560371996 sayannathcmc2@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethics Committee for Post Graduate Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Adult end stage chronic kidney disease patients undergoing renal transplant surgery,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	ropivacaine in TAP block	The skin of the patients on the side of operation was prepared from subcostal to inguinal region and area above iliac crest with 2.5% chlorhexidine solution in ethyl alcohol. With the patients in supine position a high frequency linear ultrasound probe (covered with a sterile sheath) was placed transversely to the anterolateral abdominal wall between iliac crest and subcostal margin where muscle layers are distinctly identified. After identification of the transversus abdominis plane, the probe was moved more posteriorly so as to reach the mid axillary line. The block needle (18G Tuohy needle) was introduced by in-plane approach from anterior to posterior direction so that it reached the mid axillary line in the musculofascial transversus abdominis plane. Proper placement of needle was tested by injecting 2ml of saline which created an hypoechoic zone. 20ml of 0.5% ropivacaine was then injected in that plane under real time visulisation on ultrasound. The spread of injectate in the correct plane was confirmed by ultrasound.
Intervention	ropivacaine plus clonidine in TAP block	The skin of the patients on the side of operation was prepared from subcostal to inguinal region and area above iliac crest with 2.5% chlorhexidine solution in ethyl alcohol. With the patients in supine position a high frequency linear ultrasound probe (covered with a sterile sheath) was placed transversely to the anterolateral abdominal wall between iliac crest and subcostal margin where muscle layers are distinctly identified. After identification of the transversus abdominis plane, the probe was moved more posteriorly so as to reach the mid axillary line. The block needle (18G Tuohy needle) was introduced by in-plane approach from anterior to posterior direction so that it reached the mid axillary line in the musculofascial transversus abdominis plane. Proper placement of needle was tested by injecting 2ml of saline which created an hypoechoic zone. 0.5% ropivacaine plus clonidine 2 microgram/kg making total volume of 20 ml was then injected in that plane under real time visulisation on ultrasound. The spread of injectate in the correct plane was confirmed by ultrasound.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Adult patients undergoing renal transplantation.

ExclusionCriteria

Details

1.Refusal to participate
2.Infection at site of proposed block
3.Hypersensitivity to ropivacaine, clonidine or opioids
4.Inability to understand the functioning and use of Patient Controlled Analgesia (PCA)pump or Visual analogue scale

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Post-operative 24 hour intravenous morphine consumption	0 hour,2 hours, 6 hours, 12 hours, 24 hours in post- operative period

Secondary Outcome

Outcome	TimePoints
Intra-operative total intravenous fentanyl consumption	End of surgery
Post-operative 24 hour pain scores on visual analogue scale (VAS 0-100)	0 hour,2 hours, 6 hours, 12 hours, 24 hours in the post-operative period
Number of boluses of intravenous morphine as rescue analgesia in 24 hour post-operative period	0 hour,2 hours, 6 hours, 12 hours, 24 hours in post-operative period
Time to first analgesic use in the post operative period	Time point at which first analgesic was required in the post-operative period
Side effects in the post operative period such as hypotension (blood pressure less than 25% of baseline), significant bradycardia (heart rate less than 50 beats/minute associated with hypotension),sedation (score more than 3 in Ramsay sedation scale), respiratory depression (respiratory rate less than 8 breath/minute or SpO2 less than 90% with oxygen by face mask), pruritus, post operative nausea and vomiting	0 hour, 2 hours, 6 hours, 12 hours, 24 hours in the post-operative period

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40"

Phase of Trial

N/A

Date of First Enrollment (India)

14/05/2015

Date of Study Completion (India)

15/09/2016

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

not published

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

The primary purpose of the study was to see the effect of addition of clonidine as adjuvant to ropivacaine in transversus abdominis plane block for adult renal transplant recipients in terms of post operative analgesia. Addition of clonidine does not appear to provide additional benefit.