CTRI

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CTRI Number

CTRI/2010/091/001488 [Registered on: 15/10/2010]

Last Modified On:

08/03/2013

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A research to study the efficacy of a procedure, ultrasound guided infiltration of a local anaesthetic in abdominal muscles for providing postoperative pain relief in patient who are undergoing delivery by Caesarean Section

Scientific Title of Study

Efficacy of Ultrasound guided Transversus Abdominis Plane Block for postopertive Analgesia in Caesarean Section: A Prospective Randomized Double Blinded Study.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr. Om Prakash
Designation
Affiliation
Address	Consultant, Department of Anaesthesiology and Pain Management: Max Superspeciality Hospital (West Block) 1, Press Enclave Road ; Saket New Delhi DELHI 110017 India
Phone	+91 9910300237
Fax
Email	dromprakas@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Om Prakash
Designation
Affiliation
Address	Consultant, Department of Anaesthesiology and Pain Management: Max Superspeciality Hospital (West Block) 1, Press Enclave Road ; Saket New Delhi DELHI 110017 India
Phone	+91 9910300237
Fax
Email	dromprakas@gmail.com

Details of Contact Person
Public Query

Name	Dr. Om Prakash
Designation
Affiliation
Address	Consultant, Department of Anaesthesiology and Pain Management: Max Superspeciality Hospital (West Block) 1, Press Enclave Road ; Saket New Delhi DELHI 110017 India
Phone	+91 9910300237
Fax
Email	dromprakas@gmail.com

Source of Monetary or Material Support

Max Superspeciality Hospital 1, Press Enclave Road Saket New Delhi PIN: 110017

Primary Sponsor
Modification(s)

Name	NOT APPLICABLE
Address	NOT APPLICABLE
Type of Sponsor	Other [NOT APPLICABLE]

Details of Secondary Sponsor

Name	Address
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. Om Prakash	Max Superspeciality Hospital; 1,Press Enclave Road; Saket; New Delhi - 110017	Consultant; Department of Anaesthesiology and Pain Management; Max Superspeciality Hospital,1, Press Enclave Road; Saket-110017 New Delhi DELHI	+91 9910300237 dromprakas@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 1
Name of Committee	Approval Status
Max Healthcare Ethics Committee	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Not Applicable

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Patients who are undergoing Caesarean Section under Spinal Anaesthesia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Ultrasound guided bilateral Transversus Abdominis Plane Block using 0.25%Bupivacaine Hydrochloride (A local Anaesthetic)	Performed postoperatively, 25ml of 0.25% Bupivacaine Hydrochloride infilterated on each side as a single dose
Comparator Agent	Ultrasound Guided Bilateral Transversus Abdominis Plane Block using 0.9% Normal Saline (Placebo)	Performed postoperatively, 25ml of 0.9% Normal saline infilterated on each side as a single dose

Inclusion Criteria
Modification(s)

Age From	20.00 Year(s)
Age To	42.00 Year(s)
Gender	Female
Details	Adult females of all Racial and Ethnic Group of child bearing age group undergoing Caesarean section under Spinal Anaesthesia with American Society of Anaesthesiology (ASA) Criteria I, IE(Emergency), II and IIE

ExclusionCriteria

Details

Patient with history of Chronic Obstructive Pulmonary Disease, Asthma, allergic reaction to Local Aanesthetic, opioid dependence. Patients with coagulopathy,Pre-eclampsia/eclampsia. Patients in whom adjuvent analgesia like Paracetamol and Diclofenac is contraindicated

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Requirement of Fentanyl	24Hrs

Secondary Outcome

Outcome	TimePoints
Mean Visual Analogue Score	at the end of 12 Hrs, and 24Hrs postoperatively
Mean Ramsay Sedation Score	over 24 Hrs postoperatively
Any other complication related to Transversus Abdominis Plane Block or Intravenous PCA Fentanyl	Over 24 hrs after the procedure

Target Sample Size
Modification(s)

Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

N/A

Date of First Enrollment (India)

Date Missing

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

14/09/2010

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="8"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

This is a randomized, double blinded, parellel group placebo controlled study to see the efficacy of Ultrasound guided Transversus abdominis Block in patients undergoing caesarean section under spinal anaesthesia to be conducted at Max Superspeciality hospital, Saket over a period of eight months. The Primary outcome measure will be the amount of Fentanyl required in 24 hrs postoperatively. The secondary outcome measures will be mean Visual Analogue scale at the end of 12hrs and 24hrs postoperatively, mean Ramsay Sedation Score at the end of 24hrs and any complications or side effects arising due to Transversus abdominis Plane Block or due to Patient Controlled Analgesia Fentanyl infusion postoperative period in the initial 24 hrs.