|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
24 November 2021 |
|
Main ID: |
CTRI/2018/04/013105 |
|
Date of registration:
|
09-04-2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Ultrasound guided nerve block for post-operative pain relief in breast cancer surgery:A comparison between two different concentrations of the same drug.
|
|
Scientific title:
|
Ultrasound guided Pecs block (I & II) for postoperative analgesia in breast cancer surgery:A prospective, randomized, double blind, comparative study to compare efficacy of 0.375% Ropivacaine versus low concentration 0.2% ropivacaine. |
|
Date of first enrolment:
|
30-01-2016 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17044 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Afghanistan
|
India
|
Iraq
| | | | | |
|
Contacts
|
|
Name:
|
Dr Chetan Saraya
|
|
Address:
|
OT Complex, 2nd floor
Deptt of Anesthesia
BL Kapur Memorial Hospital
New Delhi Pusa Road, New Delhi
110005
Central, DELHI
India |
|
Telephone:
|
9871531845 |
|
Email:
|
chetansaraya@hotmail.com |
|
Affiliation:
|
BL Kapur Memorial Hospital |
|
|
Name:
|
Dr UK Valecha
|
|
Address:
|
OT Complex, 2nd floor
Deptt of Anesthesia
BL Kapur Memorial Hospital
New Delhi Pusa Road, New Delhi
110005
Central, DELHI
India |
|
Telephone:
|
9871531845 |
|
Email:
|
chetansaraya@hotmail.com |
|
Affiliation:
|
BL Kapur Memorial Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1 ASA class 1 & 2
2 Patient ready to give informed consent
Exclusion criteria: 1 Age <18yrs and >70yrs
2 ASA class >2
3 Respiratory diseases
4 Hepatic diseases
5 Uncontrolled DM
6 Morbid obesity
7 Allery to local anesthetic agent or USG gel
8 H/O chronic pain
9 Drug or alcohol abuse
10 Psychological disorders
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: null- Patients diagnosed with breast carcinoma and scheduled for surgery
|
|
Intervention(s)
|
Intervention1: 0.2% Ropivacaine: Administered in Pectoral nerve block (I and II)
Control Intervention1: 0.375% Ropivacaine: Administered in Pectoral nerve block (I and II)
|
|
Primary Outcome(s)
|
Postoperative painTimepoint: 1st hour
2nd hour
4th hour
6th hour
12th hour
24th hour
|
|
Secondary Outcome(s)
|
Blood pressure, Heart rate, Respiratory rate, Oxygen saturation, Nausea and vomitingTimepoint: 1st hour
2nd hour
4th hour
6th hour
12th hour
24th hour
|
|
Source(s) of Monetary Support
|
|
BL Kapur Memorial Hospital, Pusa Road, New Delhi-110005
|
|
Ethics review
|
Status: Approved
Approval date: 27/01/2016
Contact:
DR BL KAPUR MEMORIAL HOSPITAL ETHICS COMMITTEE
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
22/10/2016 |
|
URL:
|
|
|
|